Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084897
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAM-AP-ES HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE 25MG;15MG;0.1MG 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
11/20/1979 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-35 Manufacturing (CMC)-Facility

Label is not available on this site.

07/06/1992 SUPPL-30 Labeling

Label is not available on this site.

02/11/1992 SUPPL-29 Labeling

Label is not available on this site.

03/15/1991 SUPPL-28 Labeling

Label is not available on this site.

05/09/1989 SUPPL-27 Labeling

Label is not available on this site.

06/02/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/11/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

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