List of Excipients in API ROFLUMILAST

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Excipients in NDA-approved (novel) drugs containing ROFLUMILAST

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
AstraZeneca Pharmaceuticals LP	DALIRESP	roflumilast	0310-0095	LACTOSE MONOHYDRATE
AstraZeneca Pharmaceuticals LP	DALIRESP	roflumilast	0310-0095	MAGNESIUM STEARATE
AstraZeneca Pharmaceuticals LP	DALIRESP	roflumilast	0310-0095	POVIDONE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing ROFLUMILAST

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Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	roflumilast	0378-1905	CELLULOSE, MICROCRYSTALLINE
Mylan Pharmaceuticals Inc	roflumilast	0378-1905	CROSCARMELLOSE SODIUM
Mylan Pharmaceuticals Inc	roflumilast	0378-1905	HYDROXYPROPYL CELLULOSE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for ROFLUMILAST

Excipient focus: BUTANE

ROFLUMILAST drug variants containing BUTANE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing BUTANE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: CARBOXYMETHYLCELLULOSE CALCIUM

ROFLUMILAST drug variants containing CARBOXYMETHYLCELLULOSE CALCIUM

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Company	Ingredient	NDC
Torrent Pharmaceuticals Limited	roflumilast	13668-476
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing CARBOXYMETHYLCELLULOSE CALCIUM

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

ROFLUMILAST drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
Zydus Pharmaceuticals USA Inc	roflumilast	68382-969
Zydus Lifesciences Limited	roflumilast	70771-1674
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
MAJOR PHARMACEUTICALS	roflumilast	0904-7483
>Company	>Ingredient	>NDC

Excipient focus: CETEARETH-10 PHOSPHATE

ROFLUMILAST drug variants containing CETEARETH-10 PHOSPHATE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing CETEARETH-10 PHOSPHATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: CETEARYL PHOSPHATE

ROFLUMILAST drug variants containing CETEARYL PHOSPHATE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing CETEARYL PHOSPHATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: CETOSTEARYL ALCOHOL

ROFLUMILAST drug variants containing CETOSTEARYL ALCOHOL

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing CETOSTEARYL ALCOHOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: COPOVIDONE K25-31

ROFLUMILAST drug variants containing COPOVIDONE K25-31

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Company	Ingredient	NDC
Solco Healthcare US LLC	roflumilast	43547-005
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing COPOVIDONE K25-31

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: CROSCARMELLOSE SODIUM

ROFLUMILAST drug variants containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
MAJOR PHARMACEUTICALS	roflumilast	0904-7483
>Company	>Ingredient	>NDC

Excipient focus: DIETHYLENE GLYCOL MONOETHYL ETHER

ROFLUMILAST drug variants containing DIETHYLENE GLYCOL MONOETHYL ETHER

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing DIETHYLENE GLYCOL MONOETHYL ETHER

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: HEXYLENE GLYCOL

ROFLUMILAST drug variants containing HEXYLENE GLYCOL

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing HEXYLENE GLYCOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

ROFLUMILAST drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: HYDROXYPROPYL CELLULOSE

ROFLUMILAST drug variants containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
Micro Labs Limited	roflumilast	42571-259
Solco Healthcare US LLC	roflumilast	43547-005
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
MAJOR PHARMACEUTICALS	roflumilast	0904-7483
>Company	>Ingredient	>NDC

Excipient focus: HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

ROFLUMILAST drug variants containing HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	roflumilast	68382-969
Zydus Lifesciences Limited	roflumilast	70771-1674
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2910

ROFLUMILAST drug variants containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Aurobindo Pharma Limited	roflumilast	59651-275
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: ISOBUTANE

ROFLUMILAST drug variants containing ISOBUTANE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing ISOBUTANE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: ISOPROPYL PALMITATE

ROFLUMILAST drug variants containing ISOPROPYL PALMITATE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing ISOPROPYL PALMITATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: LACTOSE MONOHYDRATE

ROFLUMILAST drug variants containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	roflumilast	31722-623
American Health Packaging	roflumilast	60687-786
Arcutis Biotherapeutics Inc	roflumilast	80610-130
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

ROFLUMILAST drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Solco Healthcare US LLC	roflumilast	43547-005
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

ROFLUMILAST drug variants containing MANNITOL

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	roflumilast	31722-623
American Health Packaging	roflumilast	60687-786
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing MANNITOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: METHYLENE CHLORIDE

ROFLUMILAST drug variants containing METHYLENE CHLORIDE

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	roflumilast	31722-623
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing METHYLENE CHLORIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: METHYLPARABEN

ROFLUMILAST drug variants containing METHYLPARABEN

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing METHYLPARABEN

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: MICROCRYSTALLINE CELLULOSE 102

ROFLUMILAST drug variants containing MICROCRYSTALLINE CELLULOSE 102

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	roflumilast	31722-623
American Health Packaging	roflumilast	60687-786
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing MICROCRYSTALLINE CELLULOSE 102

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: POLOXAMER 188

ROFLUMILAST drug variants containing POLOXAMER 188

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Company	Ingredient	NDC
Aurobindo Pharma Limited	roflumilast	59651-275
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing POLOXAMER 188

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: POLOXAMER 407

ROFLUMILAST drug variants containing POLOXAMER 407

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	roflumilast	68382-969
Zydus Lifesciences Limited	roflumilast	70771-1674
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing POLOXAMER 407

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: POLYSORBATE 80

ROFLUMILAST drug variants containing POLYSORBATE 80

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Company	Ingredient	NDC
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
MAJOR PHARMACEUTICALS	roflumilast	0904-7483
Novadoz Pharmaceuticals LLC	roflumilast	72205-200
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing POLYSORBATE 80

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
Torrent Pharmaceuticals Limited	roflumilast	13668-476
>Company	>Ingredient	>NDC

Excipient focus: POLYVINYL ALCOHOL

ROFLUMILAST drug variants containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
Torrent Pharmaceuticals Limited	roflumilast	13668-476
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE

ROFLUMILAST drug variants containing POVIDONE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing POVIDONE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
MAJOR PHARMACEUTICALS	roflumilast	0904-7483
>Company	>Ingredient	>NDC

Excipient focus: PROPANE

ROFLUMILAST drug variants containing PROPANE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing PROPANE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: PROPYLPARABEN

ROFLUMILAST drug variants containing PROPYLPARABEN

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing PROPYLPARABEN

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

ROFLUMILAST drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	roflumilast	31722-623
American Health Packaging	roflumilast	60687-786
Zydus Pharmaceuticals USA Inc	roflumilast	68382-969
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

ROFLUMILAST drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: SODIUM STEARYL FUMARATE

ROFLUMILAST drug variants containing SODIUM STEARYL FUMARATE

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Company	Ingredient	NDC
Solco Healthcare US LLC	roflumilast	43547-005
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing SODIUM STEARYL FUMARATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: STARCH, CORN

ROFLUMILAST drug variants containing STARCH, CORN

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing STARCH, CORN

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	roflumilast	31722-623
American Health Packaging	roflumilast	60687-786
Arcutis Biotherapeutics Inc	roflumilast	80610-130
>Company	>Ingredient	>NDC

Excipient focus: WATER

ROFLUMILAST drug variants containing WATER

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing WATER

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

Excipient focus: WHITE PETROLATUM

ROFLUMILAST drug variants containing WHITE PETROLATUM

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Company	Ingredient	NDC
Arcutis Biotherapeutics Inc	roflumilast	80610-130
Arcutis Biotherapeutics Inc	roflumilast	80610-430
>Company	>Ingredient	>NDC

ROFLUMILAST drug variants not containing WHITE PETROLATUM

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	roflumilast	0310-0095
Mylan Pharmaceuticals Inc	roflumilast	0378-1905
MAJOR PHARMACEUTICALS	roflumilast	0904-7399
>Company	>Ingredient	>NDC

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