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Details for New Drug Application (NDA): 090082

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NDA 090082 describes ALPRAZOLAM, which is a drug marketed by Sandoz, Roxane, Mylan, Ani Pharms Inc, Natco Pharma Ltd, Apotex Inc, Vintage Pharms, Actavis Elizabeth, Aurobindo Pharma Ltd, Mylan Pharms Inc, Watson Labs, Impax Labs, Anchen Pharms, Aurobindo Pharma Usa, Dava Intl Inc, Sandoz Inc, Sun Pharma Global, Amneal Pharms Ny, Par Pharm, Heritage Pharms Inc, Vintage, Ivax Sub Teva Pharms, Corepharma, and Actavis Labs Fl Inc, and is included in thirty-five NDAs. It is available from fifty-six suppliers. Additional details are available on the ALPRAZOLAM profile page.

The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for NDA: 090082

Tradename:
ALPRAZOLAM
Applicant:
Sun Pharma Global
Ingredient:
alprazolam
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090082

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 090082

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM
alprazolam
TABLET;ORAL 090082 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-752 35356-752-00 100 TABLET in 1 BOTTLE (35356-752-00)
ALPRAZOLAM
alprazolam
TABLET;ORAL 090082 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-752 35356-752-10 10 TABLET in 1 BOTTLE (35356-752-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jun 17, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jun 17, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 17, 2010TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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