Details for New Drug Application (NDA): 209217
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NDA 209217 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 209217
| Tradename: | CEFAZOLIN SODIUM |
| Applicant: | Qilu Antibiotics |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209217
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 209217 | ANDA | Apotex Corp. | 60505-6143 | 60505-6143-4 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6143-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6143-0) |
| CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 209217 | ANDA | Apotex Corp. | 60505-6244 | 60505-6244-4 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6244-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6244-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Oct 17, 2018 | TE: | AP | RLD: | No | ||||
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