Details for New Drug Application (NDA): 209734
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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 209734
Tradename: | ACETAZOLAMIDE |
Applicant: | Strides Pharma |
Ingredient: | acetazolamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209734
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209734
Suppliers and Packaging for NDA: 209734
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 209734 | ANDA | A-S Medication Solutions | 50090-4511 | 50090-4511-0 | 100 TABLET in 1 BOTTLE (50090-4511-0) |
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 209734 | ANDA | A-S Medication Solutions | 50090-5593 | 50090-5593-0 | 12 TABLET in 1 BOTTLE (50090-5593-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
Approval Date: | Nov 20, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Nov 20, 2017 | TE: | AB | RLD: | No |
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