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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 074463


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NDA 074463 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, Dava Pharms Inc, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, 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 seventeen 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 074463
Tradename:CIMETIDINE
Applicant:Teva
Ingredient:cimetidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074463
Medical Subject Heading (MeSH) Categories for 074463
Suppliers and Packaging for NDA: 074463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIMETIDINE cimetidine TABLET;ORAL 074463 ANDA Teva Pharmaceuticals USA, Inc. 0093-8305 0093-8305-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-8305-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:May 17, 1994TE:ABRLD:No

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