FDA Orange Book · active-ingredient family
Alprazolam
Alprazolam: 3 brands, 36 generics; first approved Nov 27, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 36 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
36
Listed patents
0
Presentations
143
Brand (NDA) products
Originator applications
- NIRAVAMRLDUCB INCNDA 02172620054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 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 — - XANAX XRRLDUPJOHNNDA 02143420034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 1MG TABLET, EXTENDED RELEASE ORAL Rx AB 2MG TABLET, EXTENDED RELEASE ORAL Rx AB 3MG TABLET, EXTENDED RELEASE ORAL Rx AB - XANAXRLDUPJOHNNDA 018276—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB
Generic (ANDA) products (36)
Abbreviated applications
- ALPRAZOLAMCHARTWELL RXANDA 20750720184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMAUROBINDO PHARMAANDA 20334620154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - ALPRAZOLAMNATCOANDA 20073920154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - ALPRAZOLAMPH HEALTHANDA 07846920114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMAUROBINDO PHARMAANDA 09087120114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 1MG TABLET, EXTENDED RELEASE ORAL Rx AB 2MG TABLET, EXTENDED RELEASE ORAL Rx AB 3MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALPRAZOLAMSTRIDES PHARMA INTLANDA 09024820104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMSUN PHARMANDA 09008220104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMACTAVIS LABS FL INCANDA 07719820104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMACTAVIS ELIZABETHANDA 07856120104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 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 - ALPRAZOLAMPH HEALTHANDA 07808820094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 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 - ALPRAZOLAMAPOTEX INCANDA 07844920084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMHERITAGE PHARMS INCANDA 07848920084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMOXFORD PHARMSANDA 07849120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMAMNEAL PHARMS NYANDA 07838720084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 1MG TABLET, EXTENDED RELEASE ORAL Rx AB 2MG TABLET, EXTENDED RELEASE ORAL Rx AB 3MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALPRAZOLAMPH HEALTHANDA 07844220074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMIMPAX LABSANDA 07796820074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMANI PHARMSANDA 07797920074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMACTAVIS ELIZABETHANDA 07805620074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 1MG TABLET, EXTENDED RELEASE ORAL Rx AB 2MG TABLET, EXTENDED RELEASE ORAL Rx AB 3MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALPRAZOLAMIMPAX LABS INCANDA 07799620074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMAPOTEX INCANDA 07774120074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMANI PHARMSANDA 07772520064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMSANDOZ INCANDA 07777720064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMPHARMOBEDIENTANDA 07739120064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET, EXTENDED RELEASE ORAL Discontinued — 0.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — 2MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALPRAZOLAMSANDOZANDA 0749091998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB - ALPRAZOLAMWATSON LABSANDA 07447919973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ALPRAZOLAMSANDOZANDA 07411219953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ALPRAZOLAMWATSON LABSANDA 07445619953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ALPRAZOLAMIVAX SUB TEVA PHARMSANDA 07429419944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMANI PHARMSANDA 07408519944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMMYLANANDA 07421519944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMRSHIKMAANDA 0743121993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML CONCENTRATE ORAL Rx — - ALPRAZOLAMROXANEANDA 0743141993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML SOLUTION ORAL Discontinued — - ALPRAZOLAMACTAVIS ELIZABETHANDA 07434219934 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - ALPRAZOLAMNOVITIUM PHARMAANDA 07417419934 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - ALPRAZOLAMPHARMOBEDIENTANDA 07404619934 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - ALPRAZOLAMROXANEANDA 07419919933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG 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
41 yr 4 mo ago
Most recent approval
8 yr 3 mo ago
Approvals span 1985–2018 across 39 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3692%
Alprazolam: 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.
