Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088212
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;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
05/26/1983 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
10/06/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

05/12/1997 SUPPL-12 Labeling

Label is not available on this site.

03/04/1991 SUPPL-9 Labeling

Label is not available on this site.

11/20/1989 SUPPL-8 Labeling

Label is not available on this site.

10/10/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/10/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/16/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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