Last Updated: September 24, 2026

Details for New Drug Application (NDA): 203411

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NDA 203411 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms, 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the nevirapine profile page.

Summary for 203411

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

Medical Subject Heading (MeSH) Categories for 203411

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

Profile for product number 001

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

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