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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020981

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NDA 020981 describes HYCAMTIN, which is a drug marketed by Sandoz and is included in two NDAs. It is available from two suppliers. Additional details are available on the HYCAMTIN profile page.

The generic ingredient in HYCAMTIN is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for 020981

Tradename:	HYCAMTIN
Applicant:	Sandoz
Ingredient:	topotecan hydrochloride
Patents:	0

Pharmacology for NDA: 020981

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 020981

Topoisomerase I Inhibitors

Suppliers and Packaging for NDA: 020981

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981	NDA	Novartis Pharmaceuticals Corporation	0078-0672	0078-0672-01	10 CAPSULE in 1 BOTTLE (0078-0672-01)
HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981	NDA	Novartis Pharmaceuticals Corporation	0078-0673	0078-0673-01	10 CAPSULE in 1 BOTTLE (0078-0673-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 0.25MG BASE
Approval Date:	Oct 11, 2007	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Oct 11, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 020981

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-001	Oct 11, 2007	5,004,758*PED	⤷ Get Started Free
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007	8,158,645	⤷ Get Started Free
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007	5,004,758*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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