Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065050
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFOXITIN | CEFOXITIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/11/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65050ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/19/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
CEFOXITIN
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 |
---|---|---|---|---|---|---|---|---|
CEFOXITIN | CEFOXITIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065415 | ACS DOBFAR |
CEFOXITIN | CEFOXITIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065050 | HIKMA |
CEFOXITIN | CEFOXITIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065239 | HIKMA FARMACEUTICA |