FDA Orange Book · active-ingredient family
Cimetidine
Cimetidine: 3 brands, 30 generics; first approved Dec 14, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 30 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
30
Listed patents
0
Presentations
79
Brand (NDA) products
Originator applications
- TAGAMET HBRLDMEDTECH PRODUCTSNDA 02023819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 200MG TABLET ORAL OTC - - TAGAMETRLDGLAXOSMITHKLINENDA 017920-4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - GLAXOSMITHKLINENDA 0209511999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML SUSPENSION ORAL Discontinued -
Generic (ANDA) products (30)
Abbreviated applications
- CIMETIDINEAUROBINDO PHARMA LTDANDA 21899720244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - CIMETIDINEBIONPHARMAANDA 21822020244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - CIMETIDINEWATSON LABS TEVAANDA 0754251999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - - CIMETIDINEIVAX SUB TEVA PHARMSANDA 0753451999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - - CIMETIDINEHIKMAANDA 07489019984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - CIMETIDINEL PERRIGO COANDA 0752851998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL OTC - - CIMETIDINEAPOTEXANDA 07494819982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - CIMETIDINECONTRACT PHARMACALANDA 0749611998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - - CIMETIDINECONTRACT PHARMACALANDA 0749631998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - - CIMETIDINEPERRIGOANDA 0749721998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - CIMETIDINESANDOZANDA 07512219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - CIMETIDINEPLIVAANDA 07456819973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - - CIMETIDINEPLIVAANDA 0745661997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Discontinued - - CIMETIDINEWATSON LABS INCANDA 07434919963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - - CIMETIDINEWATSON LABS INCANDA 0743161996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Discontinued - - CIMETIDINEUPSHER SMITH LABSANDA 07450619964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - CIMETIDINEIVAX SUB TEVA PHARMSANDA 07442419954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - CIMETIDINESANDOZANDA 07425019954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - CIMETIDINENOVITIUM PHARMAANDA 07434019952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - - CIMETIDINENOVITIUM PHARMAANDA 0743391995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Discontinued - - CIMETIDINEIVAX SUB TEVA PHARMSANDA 07440119953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - - CIMETIDINEIVAX SUB TEVA PHARMSANDA 0744021995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Discontinued - - CIMETIDINETEVAANDA 07436519954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - CIMETIDINECHARTWELL RXANDA 07410019954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - 800MG TABLET ORAL Discontinued - - CIMETIDINECYCLEANDA 07436119942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - 400MG TABLET ORAL Discontinued - - CIMETIDINECYCLEANDA 0743711994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Discontinued - - CIMETIDINECHARTWELL MOLECULESANDA 07432919944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - CIMETIDINEMYLANANDA 07424619944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - CIMETIDINETEVAANDA 07415119943 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - CIMETIDINETEVAANDA 0744631994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
43 yr 6 mo ago
Most recent approval
2 yr ago
Approvals span 1983–2024 across 33 FDA applications.
Brand (NDA) 39%
Generic (ANDA) 3091%
Cimetidine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Assyro Intelligence
Ask anything about Cimetidine
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo