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Details for New Drug Application (NDA): 077672

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NDA 077672 describes STAVUDINE, which is a drug marketed by Cipla Ltd, Hetero Labs Ltd Iii, Mylan, Aurobindo Pharma, and Matrix Labs Ltd, and is included in six NDAs. It is available from seven 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. Eight suppliers are listed for this compound. There are fourteen tentative approvals for this compound. Additional details are available on the stavudine profile page.

Summary for NDA: 077672

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 077672

Suppliers and Packaging for NDA: 077672

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 077672 ANDA Citron Pharma LLC 57237-234 57237-234-60 60 CAPSULE in 1 BOTTLE (57237-234-60)
CAPSULE;ORAL 077672 ANDA Citron Pharma LLC 57237-235 57237-235-60 60 CAPSULE in 1 BOTTLE (57237-235-60)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Dec 29, 2008TE:ABRLD:No

Summary for product number 003

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

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