Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086833
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None No No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
04/16/1980 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
10/02/2000 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/29/1997 SUPPL-25 Labeling

Label is not available on this site.

09/28/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/05/1990 SUPPL-22 Labeling

Label is not available on this site.

12/26/1989 SUPPL-21 Labeling

Label is not available on this site.

10/11/1989 SUPPL-20 Labeling

Label is not available on this site.

03/03/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/03/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/03/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/06/1989 SUPPL-16 Labeling

Label is not available on this site.

11/05/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/11/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/26/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/22/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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