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Generated: October 23, 2018

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Details for New Drug Application (NDA): 074412

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NDA 074412 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by Dava Pharms Inc, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Ani Pharms Inc, Apotex Inc, Cycle Pharms Ltd, G And W Labs Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, and Wockhardt Bio Ag, and is included in twenty-one NDAs. It is available from one supplier. Additional details are available on the CIMETIDINE HYDROCHLORIDE profile page.

The generic ingredient in CIMETIDINE HYDROCHLORIDE 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 074412
Tradename:CIMETIDINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:cimetidine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 300MG BASE/2ML
Approval Date:Mar 28, 1997TE:RLD:No

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