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NEVIRAPINE

ANDA

NEVIRAPINE | A078644 | PRINSTON PHARMACEUTICAL INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain12 active DMFs8 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDNEVIRAPINE

DMF 177822004

APITORIA PHARMA PRIVATE LTDNEVIRAPINE ANHYDROUS USP

DMF 178512004

CIPLA LTDNEVIRAPINE USP

DMF 179052004

MATRIX PHARMACORP PRIVATE LTDNEVIRAPINE USP (ANHYDROUS)

DMF 179152004

APITORIA PHARMA PRIVATE LTDNEVIRAPINE HEMIHYDRATE USP

DMF 184012005

APITORIA PHARMA PRIVATE LTDNEVIRAPINE ANHYDROUS USP

DMF 185762005

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEVIRAPINE USP

DMF 197122006

CIPLA LTDNEVIRAPINE HEMIHYDRATE USP

DMF 197532008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDNEVIRAPINE USP

DMF 212802008

APITORIA PHARMA PRIVATE LTDNEVIRAPINE ANHYDROUS USP (PROCESS II)

DMF 245202011

HETERO LABS LTDNEVIRAPINE ANHYDROUS

DMF 246102011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEVIRAPINE HEMIHYDRATE USP

DMF 296062016

MYLAN LABORATORIES LTDInactiveNEVIRAPINE HEMIHYDRATE USP

DMF 193682006

MATRIX LABORATORIES LTDInactiveNEVIRAPINE USP, NON-STERILE BULK FORM

DMF 193792005

RANBAXY LABORATORIES LTDInactiveNEVIRAPINE USP (ANHYDROUS) (NON-STERILE BULK) DRUG SUBSTANCE

DMF 200882006

ARCH PHARMALABS LTDInactiveNEVIRAPINE ANHYDROUS USP

DMF 221622008

SEQUENT SCIENTIFIC LTDInactiveNEVIRAPINE ANHYDROUS

DMF 231242009

MYLAN LABORATORIES LTDInactiveNEVIRAPINE USP (ANHYDROUS) (RAN)

DMF 233682009

MATRIX PHARMA GROUP XIAMEN LTDInactiveNEVIRAPINE ANHYDROUS USP

DMF 252212011

TYCHE INDUSTRIES LTDInactiveNEVIRAPINE

DMF 281052014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 16, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 22, 2012

No patent or exclusivity listings for this strength.