FDA Orange Book · active-ingredient family
Flurazepam hydrochloride
Flurazepam hydrochloride: 1 brand, 21 generics; first approved Nov 27, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
21
Listed patents
0
Presentations
26
Brand (NDA) products
Originator applications
- DALMANERLDVALEANT PHARM INTLNDA 016721-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - 30MG CAPSULE ORAL Discontinued -
Generic (ANDA) products (21)
Abbreviated applications
- FLURAZEPAM HYDROCHLORIDERISINGANDA 07171719912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDECHARTWELL RXANDA 0723681989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Rx AB - FLURAZEPAM HYDROCHLORIDECHARTWELL RXANDA 0723691989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - FLURAZEPAM HYDROCHLORIDESUPERPHARMANDA 0716591988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDESUPERPHARMANDA 0716601988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEHALSEYANDA 0718081988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEHALSEYANDA 0718091988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEWARNER CHILCOTTANDA 0717671987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEWARNER CHILCOTTANDA 0717681987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEPUREPAC PHARMANDA 0719271987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEPUREPAC PHARMANDA 0715511987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEUSL PHARMAANDA 0705621987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEUSL PHARMAANDA 0705631987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDEHIKMA INTL PHARMSANDA 07110819862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDECHARTWELL RXANDA 0712051986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDECHARTWELL RXANDA 0710681986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0704541986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0704551986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDENOVITIUM PHARMAANDA 0704441986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDENOVITIUM PHARMAANDA 0704451986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued - - FLURAZEPAM HYDROCHLORIDERISINGANDA 07034519852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB 15MG CAPSULE 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
41 yr 6 mo ago
Most recent approval
35 yr 9 mo ago
Approvals span 1985–1991 across 22 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2195%
Flurazepam 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.
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