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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 207507


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NDA 207507 describes ALPRAZOLAM, which is a drug marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Apotex Inc, Aurobindo Pharma, Endo Operations, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Norvium Bioscience, Sandoz Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, Sun Pharm, and Watson Labs, and is included in thirty-six NDAs. It is available from thirty-two 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. Thirty-six suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 207507
Tradename:ALPRAZOLAM
Applicant:Chartwell Rx
Ingredient:alprazolam
Patents:0
Pharmacology for NDA: 207507
Medical Subject Heading (MeSH) Categories for 207507
Suppliers and Packaging for NDA: 207507
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET;ORAL 207507 ANDA Calvin Scott & Co., Inc. 17224-624 17224-624-28 28 TABLET in 1 BOTTLE (17224-624-28)
ALPRAZOLAM alprazolam TABLET;ORAL 207507 ANDA medsource pharmaceuticals 45865-972 45865-972-30 30 TABLET in 1 BOTTLE (45865-972-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 9, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 9, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 9, 2018TE:ABRLD:No

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