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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215101


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NDA 215101 describes ACETAZOLAMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Cadila, Heritage Pharma, Indicus Pharma, Micro Labs Ltd India, Nostrum Labs Inc, Novast Labs, Rising, Ajanta Pharma Ltd, Alra, Appco, Ascot, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus Lifesciences, Avet Lifesciences, Endo Operations, Hikma, Hospira, Mylan Asi, Xgen Pharms, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from thirty-three suppliers. Additional details are available on the ACETAZOLAMIDE profile page.

The generic ingredient in ACETAZOLAMIDE is acetazolamide sodium. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 215101
Tradename:ACETAZOLAMIDE
Applicant:Rubicon
Ingredient:acetazolamide
Patents:0
Pharmacology for NDA: 215101
Mechanism of ActionCarbonic Anhydrase Inhibitors
Medical Subject Heading (MeSH) Categories for 215101
Suppliers and Packaging for NDA: 215101
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE acetazolamide TABLET;ORAL 215101 ANDA NuCare Pharmaceuticals,Inc. 68071-3550 68071-3550-1 12 TABLET in 1 BOTTLE (68071-3550-1)
ACETAZOLAMIDE acetazolamide TABLET;ORAL 215101 ANDA Bryant Ranch Prepack 71335-2215 71335-2215-1 100 TABLET in 1 BOTTLE (71335-2215-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Aug 19, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 19, 2021TE:ABRLD:No

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