Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080454
Company: WYETH AYERST
Company: WYETH AYERST
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/31/1973 | 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 |
|---|---|---|---|---|---|
| 03/04/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/22/1990 | SUPPL-15 | Bioequivalence |
Label is not available on this site. |
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| 01/22/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/22/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/22/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/24/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/23/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/23/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |