Details for New Drug Application (NDA): 211069
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NDA 211069 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.
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 211069
| Tradename: | ACETAZOLAMIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | acetazolamide |
| Patents: | 0 |
Pharmacology for NDA: 211069
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211069
Suppliers and Packaging for NDA: 211069
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 211069 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3632 | 68071-3632-1 | 100 TABLET in 1 BOTTLE (68071-3632-1) |
| ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 211069 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1238 | 70710-1238-1 | 100 TABLET in 1 BOTTLE (70710-1238-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Apr 4, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Apr 4, 2023 | TE: | AB | RLD: | No | ||||
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