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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078030

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NDA 078030 describes STAVUDINE, which is a drug marketed by Aurobindo Pharma, Hetero Labs Ltd Iii, Mylan, Mylan Labs Ltd, and Cipla Ltd, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the STAVUDINE profile page.

The generic ingredient in STAVUDINE is stavudine. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the stavudine profile page.
Summary for 078030
Tradename:STAVUDINE
Applicant:Cipla Ltd
Ingredient:stavudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078030
Medical Subject Heading (MeSH) Categories for 078030
Suppliers and Packaging for NDA: 078030
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STAVUDINE stavudine FOR SOLUTION;ORAL 078030 ANDA Cipla Ltd. 53104-0111 N 53104-0111-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength1MG/ML
Approval Date:Mar 20, 2009TE:AARLD:No

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