FDA Orange Book · active-ingredient family
Clemastine fumarate
Clemastine fumarate: 3 brands, 11 generics; first approved Jun 28, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
11
Listed patents
0
Presentations
17
Brand (NDA) products
Originator applications
- TAVIST-1RLDHALEON US HOLDINGSNDA 0209251992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.34MG TABLET ORAL Discontinued — - TAVISTRLDNOVARTISNDA 0186751985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Discontinued — - TAVISTRLDNOVARTISNDA 017661—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.68MG TABLET ORAL Discontinued — 1.34MG TABLET ORAL Discontinued — 1.34MG TABLET ORAL Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- CLEMASTINE FUMARATEAPOTEX INCANDA 0757032000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Discontinued — - CLEMASTINE FUMARATEWOCKHARDT BIO AGANDA 0748631998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Discontinued — - CLEMASTINE FUMARATENEW HEIGHTSRXANDA 0748841997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Rx AA - CLEMASTINE FUMARATEL PERRIGO COANDA 0745121995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.34MG TABLET ORAL Discontinued — - CLEMASTINE FUMARATERSGENUSANDA 0733991994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Rx AA - CLEMASTINE FUMARATEACTAVIS MID ATLANTICANDA 0740751993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Discontinued — - CLEMASTINE FUMARATEOMNIVIUM PHARMSANDA 0734591993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.68MG TABLET ORAL Discontinued — - CLEMASTINE FUMARATEPLD ACQUISITIONS LLCANDA 0734581993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.34MG TABLET ORAL Discontinued — - CLEMASTINE FUMARATETEVA PHARMSANDA 0730951992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/5ML SYRUP ORAL Discontinued — - CLEMASTINE FUMARATEANI PHARMSANDA 07328219922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.34MG TABLET ORAL Discontinued — 1.34MG TABLET ORAL Discontinued — - CLEMASTINE FUMARATERSGENUSANDA 0732831992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.68MG TABLET ORAL Rx —
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 9 mo ago
Most recent approval
26 yr 1 mo ago
Approvals span 1985–2000 across 14 FDA applications.
Brand (NDA) 321%
Generic (ANDA) 1179%
Clemastine fumarate: 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.
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- 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.
