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CIMETIDINE

ANDA

CIMETIDINE | A075345 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs16 inactive

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

CORDEN PHARMA BERGAMO SPACIMETIDINE

DMF 54971984

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)CIMETIDINE USP

DMF 109821994

SMS LIFESCIENCES INDIA LTDCIMETIDINE USP

DMF 408732024

SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINEInactiveCIMETIDINE AND CIMETIDINE HCL

DMF 27161976

SYNTEX USA INCInactiveCIMETIDINE

DMF 29911977

SK&F LAB CO SUB SK BECKMAN CORPInactiveCIMETIDINE AND CIMETIDINE HCL

DMF 32391978

SMITHKLINE AND BECKMAN INCInactiveCIMETIDINE

DMF 51231983

EURAND AMERICA INCInactiveCIMETIDINE BASE MICROCAPSULES

DMF 72341987

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveCIMETIDINE

DMF 75411988

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveCIMETIDINE HCL

DMF 78631988

APOTEX PHARMACHEM INCInactiveCIMETIDINE

DMF 80211989

1ST SOUTHWEST PHARMACEUTICAL FACTORYInactiveCIMETIDINE

DMF 83451989

QUIMICA SINTETICA SAInactiveCIMETIDINE USP XXII

DMF 84171990

IND ESQUIMEX SA KM 396 CARRETERA MEXInactiveCIMETIDINE

DMF 85361990

FIRST SOUTHWEST PHARMACEUTICAL FACTORYInactiveCIMETIDINE

DMF 89841991

GEDEON RICHTER LTDInactiveCIMETIDINE

DMF 96371992

LABORATORIO BP SRLInactiveCIMETIDINE

DMF 100291993

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveCIMETIDINE

DMF 118051996

WUXI KAILI PHARMACEUTICAL CO LTDInactiveCIMETIDINE

DMF 122631996

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 16, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 16, 1999

No patent or exclusivity listings for this strength.