Details for New Drug Application (NDA): 215101
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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 215101
Tradename: | ACETAZOLAMIDE |
Applicant: | Rubicon |
Ingredient: | acetazolamide |
Patents: | 0 |
Pharmacology for NDA: 215101
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215101
Suppliers and Packaging for NDA: 215101
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 215101 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3550 | 68071-3550-1 | 12 TABLET in 1 BOTTLE (68071-3550-1) |
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 215101 | ANDA | Bryant Ranch Prepack | 71335-2215 | 71335-2215-1 | 100 TABLET in 1 BOTTLE (71335-2215-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
Approval Date: | Aug 19, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Aug 19, 2021 | TE: | AB | RLD: | No |
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