Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065329
Company: ACS DOBFAR
Company: ACS DOBFAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2008 | 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 |
|---|---|---|---|---|---|
| 01/13/2022 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/02/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/07/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
CEFTRIAXONE
INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
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 |