Details for New Drug Application (NDA): 214282
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The generic ingredient in ACETAZOLAMIDE is acetazolamide sodium. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 214282
Tradename: | ACETAZOLAMIDE |
Applicant: | Mankind Pharma |
Ingredient: | acetazolamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214282
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 214282
Suppliers and Packaging for NDA: 214282
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 214282 | ANDA | Bryant Ranch Prepack | 63629-1194 | 63629-1194-1 | 100 TABLET in 1 BOTTLE (63629-1194-1) |
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 214282 | ANDA | Bryant Ranch Prepack | 63629-1195 | 63629-1195-1 | 100 TABLET in 1 BOTTLE (63629-1195-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
Approval Date: | Oct 7, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 7, 2020 | TE: | AB | RLD: | No |
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