Details for New Drug Application (NDA): 207659
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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 207659
Tradename: | ACETAZOLAMIDE |
Applicant: | Accord Hlthcare |
Ingredient: | acetazolamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207659
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207659
Suppliers and Packaging for NDA: 207659
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 207659 | ANDA | Accord Healthcare Inc. | 16729-331 | 16729-331-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01) |
ACETAZOLAMIDE | acetazolamide | CAPSULE, EXTENDED RELEASE;ORAL | 207659 | ANDA | Bryant Ranch Prepack | 71335-9729 | 71335-9729-1 | 180 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9729-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Oct 18, 2018 | TE: | AB | RLD: | No |
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