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Last Updated: November 6, 2025

Details for New Drug Application (NDA): 090688

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NDA 090688 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms Ltd, Mylan, Norvium Bioscience, 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 090688

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

Pharmacology for NDA: 090688

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

Medical Subject Heading (MeSH) Categories for 090688

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

Suppliers and Packaging for NDA: 090688

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEVIRAPINE	nevirapine	TABLET;ORAL	090688	ANDA	Macleods Pharmaceuticals Limited	33342-004	33342-004-09	60 TABLET in 1 BOTTLE (33342-004-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 14, 2019	TE:	AB	RLD:	No

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