Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040110
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/12/1997 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/04/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-6 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 04/28/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/26/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |