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 |
---|---|---|---|---|---|
04/30/2024 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
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. |
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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. |