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Generated: September 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079069

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NDA 079069 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 079069
Tradename:STAVUDINE
Applicant:Mylan
Ingredient:stavudine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079069
Medical Subject Heading (MeSH) Categories for 079069
Suppliers and Packaging for NDA: 079069
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STAVUDINE stavudine CAPSULE;ORAL 079069 ANDA Mylan Pharmaceuticals Inc. 0378-5041 0378-5041-91 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-5041-91)
STAVUDINE stavudine CAPSULE;ORAL 079069 ANDA Mylan Pharmaceuticals Inc. 0378-5042 0378-5042-91 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-5042-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Dec 29, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Dec 29, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Dec 29, 2008TE:ABRLD:No

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