Details for New Drug Application (NDA): 062640
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NDA 062640 describes CEFTAZIDIME, which is a drug marketed by Acs Dobfar, Aurobindo Pharma Ltd, Wockhardt, B Braun, and Baxter Hlthcare, and is included in six NDAs. It is available from two suppliers. Additional details are available on the CEFTAZIDIME profile page.
The generic ingredient in CEFTAZIDIME is ceftazidime sodium. There are seventeen drug master file entries for this compound. Additional details are available on the ceftazidime sodium profile page.
The generic ingredient in CEFTAZIDIME is ceftazidime sodium. There are seventeen drug master file entries for this compound. Additional details are available on the ceftazidime sodium profile page.
Summary for 062640
| Tradename: | CEFTAZIDIME |
| Applicant: | Acs Dobfar |
| Ingredient: | ceftazidime |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 062640
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTAZIDIME | ceftazidime | INJECTABLE;INJECTION | 062640 | ANDA | Sagent Pharmaceuticals | 25021-127 | 25021-127-20 | 25 VIAL in 1 CARTON (25021-127-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| CEFTAZIDIME | ceftazidime | INJECTABLE;INJECTION | 062640 | ANDA | Sagent Pharmaceuticals | 25021-128 | 25021-128-50 | 10 VIAL in 1 CARTON (25021-128-50) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Nov 20, 1985 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Nov 20, 1985 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Nov 20, 1985 | TE: | AP | RLD: | No | ||||
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