Details for New Drug Application (NDA): 216109
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NDA 216109 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 Antibiotics, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and Hq Spclt Pharma, and is included in thirty-four NDAs. It is available from seventeen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 216109
| Tradename: | CEFAZOLIN SODIUM |
| Applicant: | Hikma |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216109
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | cefazolin sodium | POWDER;INTRAVENOUS | 216109 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9139 | 0143-9139-25 | 25 VIAL in 1 CARTON (0143-9139-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| CEFAZOLIN SODIUM | cefazolin sodium | POWDER;INTRAVENOUS | 216109 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9140 | 0143-9140-25 | 25 VIAL in 1 CARTON (0143-9140-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Oct 7, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 3GM BASE/VIAL | ||||
| Approval Date: | Oct 7, 2022 | TE: | RLD: | Yes | |||||
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