Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040186
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 06/30/1997 | 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 |
|---|---|---|---|---|---|
| 04/30/2024 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/13/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-9 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/16/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/12/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |