Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ INC
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 | Yes |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
05/03/2005 | 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-28 | Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
03/05/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
03/05/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
03/05/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
07/13/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
07/31/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
01/14/2009 | SUPPL-3 | Labeling |
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 |
INJECTABLE;INJECTION; EQ 2GM 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 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065204 | SANDOZ INC |
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050796 | B BRAUN |