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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 075285


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NDA 075285 describes CIMETIDINE, which is a drug marketed by Apotex, Chartwell Molecules, Chartwell Rx, Contract Pharmacal, Cycle, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Novitium Pharma, Perrigo, Pliva, Sandoz, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Cosette, Endo Operations, Hospira, Luitpold, Teva Parenteral, Ani Pharms, Chartwell Molecular, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in forty-nine NDAs. It is available from sixteen suppliers. Additional details are available on the CIMETIDINE profile page.

The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 075285
Tradename:CIMETIDINE
Applicant:L Perrigo Co
Ingredient:cimetidine
Patents:0
Pharmacology for NDA: 075285
Medical Subject Heading (MeSH) Categories for 075285
Suppliers and Packaging for NDA: 075285
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIMETIDINE cimetidine TABLET;ORAL 075285 ANDA L. Perrigo Company 0113-0022 0113-0022-39 1 BOTTLE in 1 CARTON (0113-0022-39) / 30 TABLET, FILM COATED in 1 BOTTLE
CIMETIDINE cimetidine TABLET;ORAL 075285 ANDA Walgreen Company 0363-0022 0363-0022-72 1 BOTTLE in 1 CARTON (0363-0022-72) / 60 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Oct 29, 1998TE:RLD:No

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