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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 206879

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NDA 206879 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 206879

Tradename:	NEVIRAPINE
Applicant:	Macleods Pharms Ltd
Ingredient:	nevirapine
Patents:	0

Pharmacology for NDA: 206879

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

Medical Subject Heading (MeSH) Categories for 206879

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

Suppliers and Packaging for NDA: 206879

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	206879	ANDA	Macleods Pharmaceuticals Limited	33342-238	33342-238-07	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Oct 6, 2017	TE:	AB	RLD:	No

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