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Medicines · US (FDA)
Benzodiazepines

FDA 2008

Benzodiazepine derivatives

Alprazolam

Approved 17 Oct 2008OralTablet, extended release

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: ALPRAZOLAM 3MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA077968-004 · Discontinued
ALPRAZOLAM 2MG · Tablet, extended releaseANDA077968-002 · Discontinued
ALPRAZOLAM 1MG · Tablet, extended releaseANDA077968-003 · Discontinued
ALPRAZOLAM 3MG · Tablet, extended releaseANDA077968-001 · Discontinued
ALPRAZOLAM 1MG · Tablet, orally disintegratingANDA078561-003 · Prescription
ALPRAZOLAM 0.25MG · Tablet, orally disintegratingANDA078561-001 · Prescription
ALPRAZOLAM 2MG · Tablet, orally disintegratingANDA078561-004 · Prescription
ALPRAZOLAM 0.5MG · Tablet, orally disintegratingANDA078561-002 · Prescription
ALPRAZOLAM 1MG · TabletANDA200739-003 · Prescription
ALPRAZOLAM 0.25MG · TabletANDA200739-001 · Prescription
ALPRAZOLAM 2MG · TabletANDA200739-004 · Prescription
ALPRAZOLAM 0.5MG · Tablet

More in benzodiazepines

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ANDA200739-002 · Prescription

ALPRAZOLAM 2MG · TabletANDA074174-004 · Prescription

ALPRAZOLAM 0.5MG · TabletANDA074174-002 · Prescription

ALPRAZOLAM 1MG · TabletANDA074174-003 · Prescription

ALPRAZOLAM 0.25MG · TabletANDA074174-001 · Prescription

ALPRAZOLAM 1MG · TabletANDA074479-003 · Discontinued

ALPRAZOLAM 0.25MG · TabletANDA074479-001 · Discontinued

ALPRAZOLAM 0.5MG · TabletANDA074479-002 · Discontinued

ALPRAZOLAM 2MG · Tablet, extended releaseANDA078489-003 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA078489-001 · Discontinued

ALPRAZOLAM 3MG · Tablet, extended releaseThis page

ALPRAZOLAM 1MG · Tablet, extended releaseANDA078489-002 · Discontinued

ALPRAZOLAM 2MG · Tablet, extended releaseANDA077996-003 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA077996-001 · Discontinued

ALPRAZOLAM 3MG · Tablet, extended releaseANDA077996-004 · Discontinued

ALPRAZOLAM 1MG · Tablet, extended releaseANDA077996-002 · Discontinued

ALPRAZOLAM 3MG · Tablet, extended releaseANDA078387-004 · Prescription

ALPRAZOLAM 1MG · Tablet, extended releaseANDA078387-002 · Prescription

ALPRAZOLAM 2MG · Tablet, extended releaseANDA078387-003 · Prescription

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA078387-001 · Prescription

ALPRAZOLAM 1MG · TabletANDA077741-003 · Discontinued

ALPRAZOLAM 0.25MG · TabletANDA077741-001 · Discontinued

ALPRAZOLAM 2MG · TabletANDA077741-004 · Discontinued

ALPRAZOLAM 0.5MG · TabletANDA077741-002 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA078056-001 · Prescription

ALPRAZOLAM 3MG · Tablet, extended releaseANDA078056-004 · Prescription

ALPRAZOLAM 1MG · Tablet, extended releaseANDA078056-002 · Prescription

ALPRAZOLAM 2MG · Tablet, extended releaseANDA078056-003 · Prescription

ALPRAZOLAM 1MG · TabletANDA074112-003 · Prescription

ALPRAZOLAM 0.25MG · TabletANDA074112-001 · Prescription

ALPRAZOLAM 0.5MG · TabletANDA074112-002 · Prescription

ALPRAZOLAM 3MG · Tablet, extended releaseANDA077198-004 · Discontinued

ALPRAZOLAM 1MG · Tablet, extended releaseANDA077198-002 · Discontinued

ALPRAZOLAM 2MG · Tablet, extended releaseANDA077198-003 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA077198-001 · Discontinued

ALPRAZOLAM 2MG · Tablet, extended releaseANDA077777-003 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA077777-001 · Discontinued

ALPRAZOLAM 3MG · Tablet, extended releaseANDA077777-004 · Discontinued

ALPRAZOLAM 1MG · Tablet, extended releaseANDA077777-002 · Discontinued

ALPRAZOLAM 2MG · Tablet, orally disintegratingANDA078088-004 · Prescription

ALPRAZOLAM 0.5MG · Tablet, orally disintegratingANDA078088-002 · Prescription

ALPRAZOLAM 1MG · Tablet, orally disintegratingANDA078088-003 · Prescription

ALPRAZOLAM 0.25MG · Tablet, orally disintegratingANDA078088-001 · Prescription

ALPRAZOLAM 3MG · Tablet, extended releaseANDA078442-004 · Discontinued

ALPRAZOLAM 1MG · Tablet, extended releaseANDA078442-002 · Discontinued

ALPRAZOLAM 2MG · Tablet, extended releaseANDA078442-003 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA078442-001 · Discontinued

ALPRAZOLAM 0.5MG · Tablet, extended releaseANDA078469-001 · Discontinued

ALPRAZOLAM 3MG · Tablet, extended releaseANDA078469-004 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA078489.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Alprazolam
Drug class: Benzodiazepine derivatives
Group: Benzodiazepines
Route: Oral
Dosage form: Tablet, extended release
Applicant: Heritage Pharms Inc
Status: Discontinued
FDA approval: 17 Oct 2008
Application: ANDA078489-004
RxCUI: 596

Guidelines

Guidelines in psychiatry293 guidelines in the library

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FDA 2022Midazolam in 0.8% Sodium Chloridemidazolam · Solution

FDA 2021Loreev XRlorazepam · Capsule, extended release

FDA 2021Midazolam in 0.9% Sodium Chloridemidazolam · Solution

FDA 2020Chlordiazepoxide Hydrochloride and Clidinium Bromidechlordiazepoxide hydrochloride · Capsule

FDA 2020Valtocodiazepam · Spray

FDA 2019Nayzilammidazolam · Spray

FDA 2018Sympazanclobazam · Film

FDA 2018ClobazamTablet

FDA 2018Seizalammidazolam hydrochloride · Solution

FDA 2011EszopicloneTablet

FDA 2009LorazepamConcentrate

FDA 2009Edluarzolpidem tartrate · Tablet

FDA 2008ZaleplonCapsule