Details for New Drug Application (NDA): 065047
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NDA 065047 describes CEFAZOLIN SODIUM, which is a drug marketed by Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Dr Reddys, Facta Farma, Fresenius Kabi Usa, Glaxosmithkline, Hikma, Hikma Farmaceutica, Hospira, Hospira Inc, Qilu, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and Hq Spclt Pharma, and is included in thirty-four NDAs. It is available from eighteen suppliers. Additional details are available on the CEFAZOLIN SODIUM profile page.
The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 065047
| Tradename: | CEFAZOLIN SODIUM |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 065047 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9262 | 0143-9262-25 | 25 VIAL in 1 CARTON (0143-9262-25) / 3 mL in 1 VIAL (0143-9262-01) |
| CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 065047 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9923 | 0143-9923-90 | 2.2 mL in 1 VIAL (0143-9923-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Sep 18, 2001 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Sep 18, 2001 | TE: | AP | RLD: | No | ||||
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