Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090701
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFTRIAXONE SODIUM | CEFTRIAXONE 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 |
---|---|---|---|---|---|---|---|
10/04/2017 | 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 |
---|---|---|---|---|---|
01/13/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
CEFTRIAXONE 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 |
---|---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065328 | ACS DOBFAR |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209218 | QILU |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065168 | SANDOZ |
CEFTRIAXONE SODIUM | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091117 | ANDA REPOSITORY |
CEFTRIAXONE SODIUM | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090701 | HIKMA |