Details for New Drug Application (NDA): 211556
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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 211556
Tradename: | ACETAZOLAMIDE |
Applicant: | Eywa Pharma |
Ingredient: | acetazolamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211556
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211556
Suppliers and Packaging for NDA: 211556
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 211556 | ANDA | A-S Medication Solutions | 50090-5217 | 50090-5217-1 | 12 TABLET in 1 BOTTLE (50090-5217-1) |
ACETAZOLAMIDE | acetazolamide | TABLET;ORAL | 211556 | ANDA | American Health Packaging | 60687-619 | 60687-619-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-619-01) / 1 TABLET in 1 BLISTER PACK (60687-619-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
Approval Date: | Oct 18, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 18, 2019 | TE: | AB | RLD: | No |
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