Details for New Drug Application (NDA): 065306
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NDA 065306 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 sixteen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 065306
| Tradename: | CEFAZOLIN SODIUM |
| Applicant: | Acs Dobfar |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065306
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 065306 | ANDA | WG Critical Care, LLC | 44567-708 | 44567-708-10 | 10 VIAL in 1 CARTON (44567-708-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 065306 | ANDA | Fresenius Kabi USA, LLC | 63323-238 | 63323-238-61 | 10 VIAL in 1 CARTON (63323-238-61) / 1 POWDER, FOR SOLUTION in 1 VIAL (63323-238-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Oct 22, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20GM BASE/VIAL | ||||
| Approval Date: | Aug 18, 2014 | TE: | RLD: | No | |||||
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