Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065306
Company: ACS DOBFAR
Company: ACS DOBFAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/22/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/02/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/13/2013 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/18/2014 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/26/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
07/20/2010 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
CEFAZOLIN SODIUM
INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065306 | ACS DOBFAR |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065143 | HIKMA FARMACEUTICA |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209217 | QILU |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062831 | SANDOZ |