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Generated: April 26, 2017

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Details for New Drug Application (NDA): 206271

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NDA 206271 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Sandoz Inc, Aurobindo Pharma Ltd, 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 nineteen NDAs. It is available from fifteen 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. Twenty 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: 206271

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206271

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVIRAPINE
nevirapine
TABLET, EXTENDED RELEASE;ORAL 206271 ANDA Mylan Pharmaceuticals Inc. 0378-6950 0378-6950-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6950-05)
NEVIRAPINE
nevirapine
TABLET, EXTENDED RELEASE;ORAL 206271 ANDA Mylan Pharmaceuticals Inc. 0378-6950 0378-6950-77 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6950-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 9, 2015TE:ABRLD:No


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