Details for New Drug Application (NDA): 205301
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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 205301
Tradename: | ACETAZOLAMIDE |
Applicant: | Cadila |
Ingredient: | acetazolamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205301
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205301
Suppliers and Packaging for NDA: 205301
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 205301 | ANDA | American Health Packaging | 60687-578 | 60687-578-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-578-21) / 1 CAPSULE in 1 BLISTER PACK (60687-578-11) |
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 205301 | ANDA | Zydus Lifesciences Limited | 65841-762 | 65841-762-01 | 100 CAPSULE in 1 BOTTLE (65841-762-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 16, 2019 | TE: | AB | RLD: | No |
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