Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERIACTIN | CYPROHEPTADINE HYDROCHLORIDE | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/17/1961 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 02/25/2000 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 09/24/1999 | SUPPL-46 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/12649-S046_Periactin.pdf |
| 06/21/1996 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/04/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1994 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1992 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1992 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 11/04/1986 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1986 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 10/01/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1986 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/30/1984 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 04/22/1983 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 05/26/1981 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1981 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1980 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1979 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/19/1979 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 10/30/1978 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |