List of Excipients in API topotecan

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Excipients in NDA-approved (novel) drugs containing topotecan

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Novartis Pharmaceuticals Corporation	HYCAMTIN	topotecan	0078-0672	FERRIC OXIDE RED
Novartis Pharmaceuticals Corporation	HYCAMTIN	topotecan	0078-0672	GELATIN
Novartis Pharmaceuticals Corporation	HYCAMTIN	topotecan	0078-0672	GLYCERYL MONOSTEARATE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing topotecan

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Company	Ingredient	NDC	Excipient
Accord Healthcare Inc	topotecan	16729-243	HYDROCHLORIC ACID
Accord Healthcare Inc	topotecan	16729-243	SODIUM HYDROXIDE
Accord Healthcare Inc	topotecan	16729-243	TARTARIC ACID
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for topotecan

Excipient focus: FERRIC OXIDE RED

topotecan drug variants containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

topotecan drug variants not containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

Excipient focus: GELATIN

topotecan drug variants containing GELATIN

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

topotecan drug variants not containing GELATIN

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

Excipient focus: GLYCERYL MONOSTEARATE

topotecan drug variants containing GLYCERYL MONOSTEARATE

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

topotecan drug variants not containing GLYCERYL MONOSTEARATE

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

topotecan drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

topotecan drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

Excipient focus: HYDROGENATED PALM OIL

topotecan drug variants containing HYDROGENATED PALM OIL

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Company	Ingredient	NDC
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

topotecan drug variants not containing HYDROGENATED PALM OIL

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

topotecan drug variants containing MANNITOL

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Company	Ingredient	NDC
Teva Parenteral Medicines Inc	topotecan	0703-4714
Ingenus Pharmaceuticals LLC	topotecan	50742-404
Novartis Pharmaceuticals Corporation	topotecan hydrochloride	0078-0674
>Company	>Ingredient	>NDC

topotecan drug variants not containing MANNITOL

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Hospira Inc	topotecan	0409-0302
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

topotecan drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

topotecan drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

Excipient focus: TARTARIC ACID

topotecan drug variants containing TARTARIC ACID

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

topotecan drug variants not containing TARTARIC ACID

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

topotecan drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

topotecan drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

Excipient focus: WATER

topotecan drug variants containing WATER

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Company	Ingredient	NDC
Hospira Inc	topotecan	0409-0302
Teva Parenteral Medicines Inc	topotecan	0703-4714
Accord Healthcare Inc	topotecan	16729-243
>Company	>Ingredient	>NDC

topotecan drug variants not containing WATER

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	topotecan	0078-0672
Ingenus Pharmaceuticals LLC	topotecan	50742-404
Sandoz Inc	topotecan	66758-101
>Company	>Ingredient	>NDC

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