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Last Updated: October 28, 2021

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Details for New Drug Application (NDA): 214282

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NDA 214282 describes ACETAZOLAMIDE, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Cadila, Heritage Pharma, Indicus Pharma, Micro Labs Ltd India, Mylan, Nostrum Labs Inc, Novast Labs, Alra, Appco, Ascot, Breckenridge, Eywa Pharma, Lannett, Mankind Pharma, Novitium Pharma, Rubicon, Strides Pharma, Sun Pharm Industries, Taro, Vangard, Watson Labs, Emcure Pharms Ltd, Hospira, Mylan Asi, Par Sterile Products, West-ward Pharms Int, Xgen Pharms, and Zydus Pharms, and is included in thirty-two NDAs. It is available from twenty-two 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. Five suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 214282
Applicant:Mankind Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 214282
Mechanism of ActionCarbonic Anhydrase Inhibitors
Medical Subject Heading (MeSH) Categories for 214282
Suppliers and Packaging for NDA: 214282
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE acetazolamide TABLET;ORAL 214282 ANDA Bryant Ranch Prepack 63629-1194 63629-1194-1 100 TABLET in 1 BOTTLE (63629-1194-1)
ACETAZOLAMIDE acetazolamide TABLET;ORAL 214282 ANDA Bryant Ranch Prepack 63629-1195 63629-1195-1 100 TABLET in 1 BOTTLE (63629-1195-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Oct 7, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 7, 2020TE:ABRLD:No

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