Details for New Drug Application (NDA): 211413
NDA 211413 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 fourteen suppliers. Additional details are available on the CEFAZOLIN SODIUM profile page.
The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There is one drug master file entry for this compound. Sixteen 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 is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 211413
| Tradename: | CEFAZOLIN SODIUM |
| Applicant: | Hq Spclt Pharma |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211413
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | cefazolin sodium | POWDER;INTRAVENOUS | 211413 | NDA | WG Critical Care, LLC | 44567-840 | 44567-840-25 | 25 VIAL in 1 CARTON (44567-840-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-840-01) |
| CEFAZOLIN SODIUM | cefazolin sodium | POWDER;INTRAVENOUS | 211413 | NDA | WG Critical Care, LLC | 44567-845 | 44567-845-25 | 25 VIAL in 1 CARTON (44567-845-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-845-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | May 8, 2023 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 3GM BASE/VIAL | ||||
| Approval Date: | Mar 8, 2024 | TE: | RLD: | Yes | |||||
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