Last Updated: November 8, 2026

Details for New Drug Application (NDA): 218220

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NDA 218220 describes CIMETIDINE, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, 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, Hospira, Luitpold, Ph Health, Teva Parenteral, Ani Pharms, Chartwell Molecular, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in fifty-one 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 two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 218220
Tradename:CIMETIDINE
Applicant:Bionpharma
Ingredient:cimetidine
Patents:0
Pharmacology for NDA: 218220
Mechanism of ActionHistamine H2 Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 218220
Anti-Ulcer Agents
Cytochrome P-450 CYP1A2 Inhibitors
Histamine H2 Antagonists
Suppliers and Packaging for NDA: 218220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIMETIDINE cimetidine TABLET;ORAL 218220 ANDA Bionpharma Inc. 69452-323 69452-323-20 100 TABLET, FILM COATED in 1 BOTTLE (69452-323-20)
CIMETIDINE cimetidine TABLET;ORAL 218220 ANDA Bionpharma Inc. 69452-323 69452-323-30 500 TABLET, FILM COATED in 1 BOTTLE (69452-323-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 7, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 7, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 7, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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