FDA Orange Book · active-ingredient family
Clorazepate dipotassium
Clorazepate dipotassium: 1 brand, 61 generics; first approved Jun 23, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 61 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
61
Listed patents
0
Presentations
83
Brand (NDA) products
Originator applications
- TRANXENERLDAJENAT PHARMSNDA 017105—8 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — 7.5MG CAPSULE ORAL Discontinued — 15MG CAPSULE ORAL Discontinued — 22.5MG TABLET ORAL Discontinued — 11.25MG TABLET ORAL Discontinued — 3.75MG TABLET ORAL Discontinued — 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Discontinued —
Generic (ANDA) products (61)
Abbreviated applications
- CLORAZEPATE DIPOTASSIUMNOVITIUM PHARMAANDA 21373020223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - CLORAZEPATE DIPOTASSIUMCOREPHARMAANDA 21556620223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - CLORAZEPATE DIPOTASSIUMSUN PHARM INDS LTDANDA 07691120043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — 7.5MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMTAROANDA 07573120003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB 3.75MG TABLET ORAL Rx AB - CLORAZEPATE DIPOTASSIUMAUROLIFE PHARMA LLCANDA 07251419903 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 3.75MG TABLET ORAL Discontinued — 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 0715491988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 0715501988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 0715221988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMRISINGANDA 07211219883 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — 3.75MG CAPSULE ORAL Discontinued — 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 0723301988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 0723311988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 0723321988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - ALRAANDA 0717871988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - ALRAANDA 0717881988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - ALRAANDA 0717891988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 0719241988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 0719251988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMPUREPAC PHARMANDA 0719261988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 0718781988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 0718791988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 0718601988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 0718281988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 0718291988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 0718301988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 0717741988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 0717751988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWARNER CHILCOTTANDA 0717761988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 0718521988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 0718531988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMWATSON LABSANDA 0718541988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMGD SEARLE LLCANDA 0717271987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMGD SEARLE LLCANDA 0717281987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMGD SEARLE LLCANDA 0717291987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMLEDERLEANDA 0720131987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMLEDERLEANDA 0720141987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMLEDERLEANDA 0720151987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMDAVA PHARMS INCANDA 0717421987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMDAVA PHARMS INCANDA 0717431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMDAVA PHARMS INCANDA 0717441987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 0717301987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 0717311987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMQUANTUM PHARMICSANDA 0717021987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMNATCO PHARMA USAANDA 0715091987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMNATCO PHARMA USAANDA 0715101987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMNATCO PHARMA USAANDA 0715111987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAUROBINDO PHARMAANDA 07185819873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 3.75MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB - CLORAZEPATE DIPOTASSIUMABLEANDA 0717771987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMABLEANDA 0717781987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMABLEANDA 0717791987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMABLEANDA 0717801987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMABLEANDA 0717811987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMABLEANDA 0717821987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAM THERAPANDA 0714291987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAM THERAPANDA 0714301987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAM THERAPANDA 0714311987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMUSL PHARMAANDA 0712421987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMUSL PHARMAANDA 0712431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMUSL PHARMAANDA 0712441987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAM THERAPANDA 0717471987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAM THERAPANDA 0717481987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued — - CLORAZEPATE DIPOTASSIUMAM THERAPANDA 0717491987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET 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
39 yr 9 mo ago
Most recent approval
3 yr 9 mo ago
Approvals span 1987–2022 across 62 FDA applications.
Brand (NDA) 12%
Generic (ANDA) 6198%
Clorazepate dipotassium: 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.
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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.
