Details for New Drug Application (NDA): 040784
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The generic ingredient in ACETAZOLAMIDE SODIUM 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 040784
Tradename: | ACETAZOLAMIDE SODIUM |
Applicant: | Xgen Pharms |
Ingredient: | acetazolamide sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040784
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 040784
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE SODIUM | acetazolamide sodium | INJECTABLE;INJECTION | 040784 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0190 | 39822-0190-1 | 1 VIAL, GLASS in 1 CARTON (39822-0190-1) / 5 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Dec 10, 2008 | TE: | AP | RLD: | No |
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