List of Excipients in API gefitinib

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Excipients in NDA-approved (novel) drugs containing gefitinib

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
AstraZeneca Pharmaceuticals LP	IRESSA	gefitinib	0310-0482	CELLULOSE, MICROCRYSTALLINE
AstraZeneca Pharmaceuticals LP	IRESSA	gefitinib	0310-0482	CROSCARMELLOSE SODIUM
AstraZeneca Pharmaceuticals LP	IRESSA	gefitinib	0310-0482	FERRIC OXIDE RED
AstraZeneca Pharmaceuticals LP	IRESSA	gefitinib	0310-0482	FERRIC OXIDE YELLOW
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing gefitinib

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Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals Inc	gefitinib	0480-4053	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals Inc	gefitinib	0480-4053	CROSCARMELLOSE SODIUM
Teva Pharmaceuticals Inc	gefitinib	0480-4053	FERRIC OXIDE RED
Teva Pharmaceuticals Inc	gefitinib	0480-4053	FERRIC OXIDE YELLOW
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for gefitinib

Excipient focus: CELLULOSE, MICROCRYSTALLINE

gefitinib drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

Excipient focus: CROSCARMELLOSE SODIUM

gefitinib drug variants containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: CROSPOVIDONE

gefitinib drug variants containing CROSPOVIDONE

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing CROSPOVIDONE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

Excipient focus: DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

gefitinib drug variants containing DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE RED

gefitinib drug variants containing FERRIC OXIDE RED

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing FERRIC OXIDE RED

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE YELLOW

gefitinib drug variants containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

gefitinib drug variants containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Apotex Corp	gefitinib	60505-4512
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE

gefitinib drug variants containing HYPROMELLOSE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
>Company	>Ingredient	>NDC

gefitinib drug variants not containing HYPROMELLOSE

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Company	Ingredient	NDC
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

Excipient focus: LACTOSE MONOHYDRATE

gefitinib drug variants containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

gefitinib drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: MICROCRYSTALLINE CELLULOSE 101

gefitinib drug variants containing MICROCRYSTALLINE CELLULOSE 101

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Company	Ingredient	NDC
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

gefitinib drug variants not containing MICROCRYSTALLINE CELLULOSE 101

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: MICROCRYSTALLINE CELLULOSE 102

gefitinib drug variants containing MICROCRYSTALLINE CELLULOSE 102

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Company	Ingredient	NDC
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

gefitinib drug variants not containing MICROCRYSTALLINE CELLULOSE 102

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL

gefitinib drug variants containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 300

gefitinib drug variants containing POLYETHYLENE GLYCOL 300

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POLYETHYLENE GLYCOL 300

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Company	Ingredient	NDC
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 3350

gefitinib drug variants containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Apotex Corp	gefitinib	60505-4512
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 8000

gefitinib drug variants containing POLYETHYLENE GLYCOL 8000

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POLYETHYLENE GLYCOL 8000

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

Excipient focus: POLYVINYL ALCOHOL

gefitinib drug variants containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE

gefitinib drug variants containing POVIDONE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POVIDONE

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Company	Ingredient	NDC
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K30

gefitinib drug variants containing POVIDONE K30

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Company	Ingredient	NDC
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
Natco Pharma USA LLC	gefitinib	69339-168
>Company	>Ingredient	>NDC

gefitinib drug variants not containing POVIDONE K30

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

gefitinib drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

Excipient focus: SODIUM LAURYL SULFATE

gefitinib drug variants containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

Excipient focus: TALC

gefitinib drug variants containing TALC

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Company	Ingredient	NDC
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
Qilu Pharmaceutical Co Ltd	gefitinib	67184-0531
>Company	>Ingredient	>NDC

gefitinib drug variants not containing TALC

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

gefitinib drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	gefitinib	0310-0482
Teva Pharmaceuticals Inc	gefitinib	0480-4053
Ingenus Pharmaceuticals LLC	gefitinib	50742-366
Apotex Corp	gefitinib	60505-4512
>Company	>Ingredient	>NDC

gefitinib drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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