Details for New Drug Application (NDA): 204691
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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 204691
Tradename: | ACETAZOLAMIDE |
Applicant: | Nostrum Labs Inc |
Ingredient: | acetazolamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204691
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204691
Suppliers and Packaging for NDA: 204691
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 204691 | ANDA | Nostrum Laboratories, Inc. | 29033-030 | 29033-030-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-030-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 29, 2016 | TE: | AB | RLD: | No |
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