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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210588


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NDA 210588 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, Eywa Pharma, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus, Avet Lifesciences, Hikma, Hospira, Mylan Asi, Par Sterile Products, Xgen Pharms, and Zydus Pharms, and is included in thirty-six NDAs. It is available from thirty-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. Seven suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 210588
Tradename:ACETAZOLAMIDE
Applicant:Novitium Pharma
Ingredient:acetazolamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210588
Mechanism of ActionCarbonic Anhydrase Inhibitors
Medical Subject Heading (MeSH) Categories for 210588
Suppliers and Packaging for NDA: 210588
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE acetazolamide TABLET;ORAL 210588 ANDA Marlex Pharmaceuticals, Inc. 10135-772 10135-772-01 100 TABLET in 1 BOTTLE (10135-772-01)
ACETAZOLAMIDE acetazolamide TABLET;ORAL 210588 ANDA Marlex Pharmaceuticals, Inc. 10135-773 10135-773-01 100 TABLET in 1 BOTTLE (10135-773-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Oct 17, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 17, 2019TE:ABRLD:No

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