Last Updated: August 9, 2026

Details for New Drug Application (NDA): 205258

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NDA 205258 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms Ltd, Mylan, Pharmobedient, Sandoz, Tech Organized, Apotex Inc, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Pharms Inc, Prinston Inc, and Strides Pharma, and is included in twenty-three NDAs. It is available from six 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. Six suppliers are listed for this compound. Additional details are available on the nevirapine profile page.

Summary for 205258

Tradename:	NEVIRAPINE
Applicant:	Apotex
Ingredient:	nevirapine
Patents:	0

Medical Subject Heading (MeSH) Categories for 205258

Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Apr 3, 2014	TE:		RLD:	No

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