FDA Orange Book · active-ingredient family
Cimetidine hydrochloride
Cimetidine hydrochloride: 3 brands, 21 generics; first approved Oct 31, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
21
Listed patents
0
Presentations
29
Brand (NDA) products
Originator applications
- GLAXOSMITHKLINENDA 0194341985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINENDA 017939—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINENDA 017924—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued —
Generic (ANDA) products (21)
Abbreviated applications
- CIMETIDINE HYDROCHLORIDEPHARM ASSOCANDA 0755602000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDEANI PHARMSANDA 0748591998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDEANI PHARMSANDA 0751101998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDETEVA PARENTERALANDA 0742521997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDERSPAI HOLDINGS PHARMANDA 0746641997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Rx AA - CIMETIDINE HYDROCHLORIDEPHARMOBEDIENT CNSLTGANDA 0747571997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDECYCLEANDA 0745411997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDEHOSPIRAANDA 0742961997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEHOSPIRAANDA 0744121997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEPHARM ASSOCANDA 0745531997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDEANI PHARMSANDA 0746101996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued — - CIMETIDINE HYDROCHLORIDEPH HEALTHANDA 0744281996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEHOSPIRAANDA 0743441995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEHOSPIRAANDA 0743451995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEHOSPIRAANDA 0744221995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07446819946 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 360MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 480MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 180MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 240MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 90MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 120MG BASE/100ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0742691994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDECHARTWELL MOLECULARANDA 0742511994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Rx AA - CIMETIDINE HYDROCHLORIDELUITPOLDANDA 0743531994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEPH HEALTHANDA 0740051994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/2ML INJECTABLE INJECTION Discontinued — - CIMETIDINE HYDROCHLORIDEG AND W LABS INCANDA 0741761994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/5ML SOLUTION ORAL Discontinued —
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
41 yr 5 mo ago
Most recent approval
26 yr 10 mo ago
Approvals span 1985–2000 across 24 FDA applications.
Brand (NDA) 313%
Generic (ANDA) 2188%
Cimetidine hydrochloride: 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.
