Details for New Drug Application (NDA): 206533
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NDA 206533 describes ACETAZOLAMIDE SODIUM, which is a drug marketed by Avet Lifesciences, Endo Operations, Hikma, Hospira, Mylan Asi, Xgen Pharms, and Zydus Pharms, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the ACETAZOLAMIDE SODIUM profile page.
The generic ingredient in ACETAZOLAMIDE SODIUM 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.
The generic ingredient in ACETAZOLAMIDE SODIUM 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 206533
| Tradename: | ACETAZOLAMIDE SODIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | acetazolamide sodium |
| Patents: | 0 |
Pharmacology for NDA: 206533
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 206533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE SODIUM | acetazolamide sodium | INJECTABLE;INJECTION | 206533 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-076 | 68382-076-10 | 1 VIAL in 1 CARTON (68382-076-10) / 5 mL in 1 VIAL |
| ACETAZOLAMIDE SODIUM | acetazolamide sodium | INJECTABLE;INJECTION | 206533 | ANDA | Zydus Lifesciences Limited | 70771-1490 | 70771-1490-1 | 1 VIAL in 1 CARTON (70771-1490-1) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Apr 15, 2019 | TE: | AP | RLD: | No | ||||
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