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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 077521

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NDA 077521 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 077521

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

Pharmacology for NDA: 077521

Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Non-Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 077521

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

Suppliers and Packaging for NDA: 077521

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEVIRAPINE	nevirapine	TABLET;ORAL	077521	ANDA	Aurobindo Pharma Limited	65862-027	65862-027-10	6 BLISTER PACK in 1 CARTON (65862-027-10) / 10 TABLET in 1 BLISTER PACK
NEVIRAPINE	nevirapine	TABLET;ORAL	077521	ANDA	Aurobindo Pharma Limited	65862-027	65862-027-60	60 TABLET in 1 BOTTLE (65862-027-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 22, 2012	TE:	AB	RLD:	No

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