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Details for New Drug Application (NDA): 077702

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NDA 077702 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Sandoz Inc, Alvogen Malta, Apotex Inc, Mylan Pharms Inc, Prinston Inc, Cipla Ltd, Cipla, Mylan Labs, Sciegen Pharms Inc, Micro Labs Ltd, Hetero Labs Ltd Iii, and Strides Pharma, and is included in seventeen NDAs. It is available from fourteen suppliers. Additional details are available on the NEVIRAPINE profile page.

The generic ingredient in NEVIRAPINE is nevirapine. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the nevirapine profile page.

Summary for NDA: 077702

Tradename:
NEVIRAPINE
Applicant:
Aurobindo
Ingredient:
nevirapine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVIRAPINE
nevirapine
SUSPENSION;ORAL 077702 ANDA Aurobindo Pharma Limited 65862-057 65862-057-11 100 mL in 1 BOTTLE (65862-057-11)
NEVIRAPINE
nevirapine
SUSPENSION;ORAL 077702 ANDA Aurobindo Pharma Limited 65862-057 65862-057-24 240 mL in 1 BOTTLE (65862-057-24)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/5ML
Approval Date:May 22, 2012TE:AARLD:No


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