Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1985 | 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-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2023 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/04/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-27 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 04/28/2017 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2012 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2011 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2009 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/26/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/19/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |