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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087056
Company: HERITAGE PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
01/10/1980 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
03/20/2009 SUPPL-45 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf
07/29/2002 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.
10/04/2002 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/12/2001 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.
10/26/2000 SUPPL-34 Labeling

Label is not available on this site.
07/25/2000 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/28/2000 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.
09/24/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
08/20/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
09/24/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
09/24/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
12/09/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
10/17/1997 SUPPL-26 Labeling

Label is not available on this site.
03/10/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
05/30/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
10/13/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
07/27/1989 SUPPL-21 Labeling

Label is not available on this site.
11/12/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
11/12/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
03/06/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
03/08/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
11/02/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
11/12/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/20/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf
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