Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010021
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLACIDYL | ETHCHLORVYNOL | 500MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PLACIDYL | ETHCHLORVYNOL | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PLACIDYL | ETHCHLORVYNOL | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PLACIDYL | ETHCHLORVYNOL | 750MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/10/1961 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/08/1998 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/19/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1989 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/03/1987 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1986 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/01/1982 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/22/1982 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 11/19/1981 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/08/1983 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 03/12/1986 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/06/1981 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/1979 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 05/07/1976 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/10/1976 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |