Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065180
Company: WOCKHARDT
Company: WOCKHARDT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM 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 |
---|---|---|---|---|---|---|---|
05/12/2006 | 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-11 | Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/02/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/02/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
CEFTRIAXONE
INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065204 | SANDOZ INC |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065180 | WOCKHARDT |
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050796 | B BRAUN |