Details for New Drug Application (NDA): 211372
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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 211372
Tradename: | ACETAZOLAMIDE |
Applicant: | Appco |
Ingredient: | acetazolamide |
Patents: | 0 |
Pharmacology for NDA: 211372
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211372
Suppliers and Packaging for NDA: 211372
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 211372 | ANDA | TRUPHARMA, LLC | 52817-200 | 52817-200-00 | 1000 TABLET in 1 BOTTLE, PLASTIC (52817-200-00) |
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 211372 | ANDA | TRUPHARMA, LLC | 52817-200 | 52817-200-10 | 100 TABLET in 1 BOTTLE, PLASTIC (52817-200-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
Approval Date: | Feb 22, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Feb 22, 2021 | TE: | AB | RLD: | No |
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