Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081309
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE | MEPERIDINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/1993 | 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. |
||
| 10/11/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-8 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/18/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |