Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013220
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERIACTIN CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
03/30/1962 ORIG-1 Approval Type 3 - New Dosage Form 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
06/21/1996 SUPPL-41 Labeling

Label is not available on this site.

08/05/1992 SUPPL-39 Labeling

Label is not available on this site.

10/16/1992 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1989 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1986 SUPPL-36 Labeling

Label is not available on this site.

11/04/1986 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1986 SUPPL-34 Labeling

Label is not available on this site.

11/04/1986 SUPPL-33 Labeling

Label is not available on this site.

10/01/1985 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1984 SUPPL-31 Labeling

Label is not available on this site.

04/30/1984 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/22/1983 SUPPL-29 Labeling

Label is not available on this site.

05/04/1981 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1980 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1980 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1979 SUPPL-25 Labeling

Label is not available on this site.

05/29/1979 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1978 SUPPL-23 Labeling

Label is not available on this site.

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