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Details for New Drug Application (NDA): 205258

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NDA 205258 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: 205258

Apotex Inc
Therapeutic Class:Antivirals

Suppliers and Packaging for NDA: 205258

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, EXTENDED RELEASE;ORAL 205258 ANDA Apotex Corp 60505-4058 60505-4058-0 10 BLISTER PACK in 1 CARTON (60505-4058-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
TABLET, EXTENDED RELEASE;ORAL 205258 ANDA Apotex Corp 60505-4058 60505-4058-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4058-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Apr 3, 2014TE:ABRLD:No

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