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Last Updated: October 18, 2021

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Details for New Drug Application (NDA): 210423

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NDA 210423 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 210423
Applicant:Alembic Pharms Ltd
Formulation / Manufacturing:see details
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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