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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 one supplier. 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. Thirteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for NDA: 020671

Tradename:
HYCAMTIN
Applicant:
Novartis Pharms Corp
Ingredient:
topotecan hydrochloride
Patents:0
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
HYCAMTIN
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
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
HYCAMTIN
topotecan hydrochloride
INJECTABLE;INJECTION020671-001May 28, 19965,004,758*PED► subscribe
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
INJECTABLE;INJECTION020671-001May 28, 19965,674,872*PED► subscribe
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