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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210423


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NDA 210423 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 210423
Tradename:ACETAZOLAMIDE
Applicant:Alembic
Ingredient:acetazolamide
Patents:0
Pharmacology for NDA: 210423
Mechanism of ActionCarbonic Anhydrase Inhibitors
Medical Subject Heading (MeSH) Categories for 210423
Suppliers and Packaging for NDA: 210423
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE acetazolamide CAPSULE, EXTENDED RELEASE;ORAL 210423 ANDA Alembic Pharmaceuticals Limited 46708-349 46708-349-31 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31)
ACETAZOLAMIDE acetazolamide CAPSULE, EXTENDED RELEASE;ORAL 210423 ANDA Alembic Pharmaceuticals Limited 46708-349 46708-349-91 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Feb 19, 2019TE:ABRLD:No

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