List of Excipients in API AMBRISENTAN

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Excipients in NDA-approved (novel) drugs containing AMBRISENTAN

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Gilead Sciences Inc	LETAIRIS	ambrisentan	61958-0801	ALUMINUM OXIDE
Gilead Sciences Inc	LETAIRIS	ambrisentan	61958-0801	CELLULOSE, MICROCRYSTALLINE
Gilead Sciences Inc	LETAIRIS	ambrisentan	61958-0801	CROSCARMELLOSE SODIUM
Gilead Sciences Inc	LETAIRIS	ambrisentan	61958-0801	FD&C RED NO. 40
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing AMBRISENTAN

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Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270	ANHYDROUS LACTOSE
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270	CELLULOSE, MICROCRYSTALLINE
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270	CROSCARMELLOSE SODIUM
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270	FD&C BLUE NO. 2
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for AMBRISENTAN

Excipient focus: ALUMINUM OXIDE

AMBRISENTAN drug variants containing ALUMINUM OXIDE

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Company	Ingredient	NDC
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
Apotex Corp	ambrisentan	60505-4552
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing ALUMINUM OXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
Par Pharmaceutical Inc	ambrisentan	49884-353
Aurobindo Pharma Limited	ambrisentan	59651-494
>Company	>Ingredient	>NDC

Excipient focus: ANHYDROUS LACTOSE

AMBRISENTAN drug variants containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Par Pharmaceutical Inc	ambrisentan	49884-353
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

AMBRISENTAN drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: CROSCARMELLOSE SODIUM

AMBRISENTAN drug variants containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 2

AMBRISENTAN drug variants containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
Par Pharmaceutical Inc	ambrisentan	49884-353
Aurobindo Pharma Limited	ambrisentan	59651-494
>Company	>Ingredient	>NDC

Excipient focus: FD&C RED NO. 40

AMBRISENTAN drug variants containing FD&C RED NO. 40

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing FD&C RED NO. 40

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
>Company	>Ingredient	>NDC

Excipient focus: FD&C YELLOW NO. 6

AMBRISENTAN drug variants containing FD&C YELLOW NO. 6

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Company	Ingredient	NDC
Apotex Corp	ambrisentan	60505-4552
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing FD&C YELLOW NO. 6

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

Excipient focus: LACTOSE MONOHYDRATE

AMBRISENTAN drug variants containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Par Pharmaceutical Inc	ambrisentan	49884-353
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
>Company	>Ingredient	>NDC

Excipient focus: LECITHIN, SOYBEAN

AMBRISENTAN drug variants containing LECITHIN, SOYBEAN

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
Par Pharmaceutical Inc	ambrisentan	49884-353
Aurobindo Pharma Limited	ambrisentan	59651-494
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing LECITHIN, SOYBEAN

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Apotex Corp	ambrisentan	60505-4552
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

AMBRISENTAN drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL

AMBRISENTAN drug variants containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Zydus Pharmaceuticals USA Inc	ambrisentan	70710-1179
Zydus Lifesciences Limited	ambrisentan	70771-1363
Quallent Pharmaceuticals Health LLC	ambrisentan	82009-141
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 3350

AMBRISENTAN drug variants containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Par Pharmaceutical Inc	ambrisentan	49884-353
Cipla USA Inc	ambrisentan	69097-386
Zydus Pharmaceuticals USA Inc	ambrisentan	70710-1179
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 4000

AMBRISENTAN drug variants containing POLYETHYLENE GLYCOL 4000

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Company	Ingredient	NDC
Par Pharmaceutical Inc	ambrisentan	49884-353
Cipla USA Inc	ambrisentan	69097-386
Exelan Pharmaceuticals Inc	ambrisentan	76282-684
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing POLYETHYLENE GLYCOL 4000

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

Excipient focus: POLYVINYL ALCOHOL

AMBRISENTAN drug variants containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE

AMBRISENTAN drug variants containing POVIDONE

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	ambrisentan	70710-1179
Zydus Lifesciences Limited	ambrisentan	70771-1363
Quallent Pharmaceuticals Health LLC	ambrisentan	82009-141
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing POVIDONE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

AMBRISENTAN drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Sun Pharmaceutical Industries Inc	ambrisentan	47335-236
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

Excipient focus: TALC

AMBRISENTAN drug variants containing TALC

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing TALC

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

AMBRISENTAN drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	ambrisentan	0378-4270
Actavis Pharma Inc	ambrisentan	0591-2405
AvKARE	ambrisentan	42291-018
Sigmapharm Laboratories LLC	ambrisentan	42794-051
>Company	>Ingredient	>NDC

AMBRISENTAN drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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