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Last Updated: March 19, 2024

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 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. Six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020671
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 020671
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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:May 28, 1996TE:APRLD:Yes

Expired US Patents for NDA 020671

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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