Viewing data from:

NABUMETONE

ANDA

NABUMETONE | A075280 | CHARTWELL RX SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs14 inactive

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

DIVIS LABORATORIES LTDNABUMETONE USP

DMF 153642001

MATRIX PHARMACORP PRIVATE LTDNABUMETONE USP

DMF 182122005

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDNABUMETONE USP

DMF 185812005

ERREGIERRE SPANABUMETONE USP

DMF 192432006

TAPI NL BVNABUMETONE USP

DMF 222582008

HETERO DRUGS LTDNABUMETONE

DMF 267472012

ESTEVE QUIMICA SAInactiveNABUMETONE

DMF 119841996

DINAMITE DIPHARMA SPAInactiveNABUMETONE

DMF 120911996

CHEMI SPAInactiveNABUMETONE

DMF 122961996

NAPP TECHNOLOGIES INCInactiveNABUMETONE

DMF 124451997

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveNABUMETONE

DMF 126231997

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveNABUMETONE

DMF 131051998

API INCInactiveNABUMETONE DRUG SUBSTANCE

DMF 141741999

ERREGIERRE SPAInactiveNABUMETONE

DMF 146001999

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDInactiveNABUMETONE(BULK)

DMF 148042000

RECORDATI CORPInactiveNABUMETONE

DMF 154912001

IPCA LABORATORIES LTDInactiveNABUMETONE

DMF 175662004

JIANGSU ZHONGDAN PHARMACEUTICAL CO LTDInactiveNABUMETONE

DMF 189762007

IPCA LABORATORIES LTDInactiveNABUMETONE USP, PROCESS II

DMF 206202007

LUPIN LTDInactiveNABUMETONE (MICRONISED) USP

DMF 214672008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2004	ORIG -1	View Letter (PDF)
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 25, 2002

No patent or exclusivity listings for this strength.

#002 — 750MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 25, 2002