Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080448
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 10/15/1976 | 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 |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 04/30/2024 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 12/15/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 09/18/2018 | SUPPL-21 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 05/08/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/16/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/14/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |