FDA Orange Book · active-ingredient family
Clonazepam
Clonazepam: 2 brands, 17 generics; first approved Sep 10, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
17
Listed patents
0
Presentations
71
Brand (NDA) products
Originator applications
- ROCHENDA 02081319975 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 0.25MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 0.5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 1MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 2MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - KLONOPINRLDCHEPLAPHARMNDA 017533—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 0.125MG TABLET ORAL Discontinued — 0.25MG TABLET ORAL Discontinued —
Generic (ANDA) products (17)
Abbreviated applications
- CLONAZEPAMRUBICON RESEARCHANDA 21698820265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 1MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 2MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLONAZEPAMALEMBICANDA 21103320195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 1MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 2MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLONAZEPAMSUN PHARM INDS INCANDA 07865420145 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 0.25MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 0.5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 1MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 2MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - CLONAZEPAMPRINSTON INCANDA 07785620063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMBARRANDA 07719420055 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 1MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 2MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLONAZEPAMPH HEALTHANDA 07717120055 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 0.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 1MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 2MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLONAZEPAMACCORD HLTHCAREANDA 07714720053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMSUN PHARM INDS INCANDA 07542320013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - CLONAZEPAMRUBICON RESEARCHANDA 07546820003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMAUROBINDO PHARMA USAANDA 07515019983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMTEVAANDA 07492019983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - CLONAZEPAMWATSON LABSANDA 07496419973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - CLONAZEPAMQUAGENANDA 07494019973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - CLONAZEPAMCHARTWELL RXANDA 07492519973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMSANDOZANDA 07497919973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMACTAVIS ELIZABETHANDA 07486919963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - CLONAZEPAMTEVAANDA 07456919963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG 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
30 yr 4 mo ago
Most recent approval
3 mo ago
Approvals span 1996–2026 across 19 FDA applications.
Brand (NDA) 211%
Generic (ANDA) 1789%
Clonazepam: 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.
