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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020671

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NDA 020671 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 020671

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

Pharmacology for NDA: 020671

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 020671

Topoisomerase I Inhibitors

Suppliers and Packaging for NDA: 020671

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671	NDA	Novartis Pharmaceuticals Corporation	0078-0674	0078-0674-61	1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4MG BASE/VIAL
Approval Date:	May 28, 1996	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020671

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996	5,004,758*PED	⤷ Get Started Free
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996	5,674,872*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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