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Details for New Drug Application (NDA): 020671

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NDA 020671 describes HYCAMTIN, which is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug. 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. Fourteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for NDA: 020671

Novartis Pharms Corp
topotecan hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 020671

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 020671

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
topotecan hydrochloride
INJECTABLE;INJECTION 020671 NDA GlaxoSmithKline LLC 0007-4201 0007-4201-01 1 VIAL in 1 PACKAGE (0007-4201-01) > 4 mL in 1 VIAL
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

Summary for product number 001

Approval Date:May 28, 1996TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020671

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
topotecan hydrochloride
INJECTABLE;INJECTION020671-001May 28, 19965,004,758*PED► subscribe
Novartis Pharms Corp
topotecan hydrochloride
INJECTABLE;INJECTION020671-001May 28, 19965,674,872*PED► subscribe
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