Details for New Drug Application (NDA): 210423
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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 210423
Tradename: | ACETAZOLAMIDE |
Applicant: | Alembic |
Ingredient: | acetazolamide |
Patents: | 0 |
Pharmacology for NDA: 210423
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 210423
Suppliers and Packaging for NDA: 210423
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 210423 | ANDA | Alembic Pharmaceuticals Limited | 46708-349 | 46708-349-31 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31) |
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 210423 | ANDA | Alembic Pharmaceuticals Limited | 46708-349 | 46708-349-91 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 19, 2019 | TE: | AB | RLD: | No |
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