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Details for New Drug Application (NDA): 020981


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NDA 020981 describes HYCAMTIN, which is a drug marketed by Novartis 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. Eleven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 020981
Tradename:HYCAMTIN
Applicant:Novartis
Ingredient:topotecan hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 020981
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 020981
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:RXDosage:CAPSULE;ORALStrengthEQ 0.25MG BASE
Approval Date:Oct 11, 2007TE:RLD:Yes
Patent:  Try Before You BuyPatent Expiration:Dec 10, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Oct 11, 2007TE:RLD:Yes
Patent:  Try Before You BuyPatent Expiration:Dec 10, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020981

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007   Try Before You Buy   Try Before You Buy
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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