Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065125
Company: LUPIN
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065125.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2022 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2020 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2020 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2016 | SUPPL-17 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/09/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |