Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088570
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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
04/10/1984 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
12/01/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/13/1992 SUPPL-17 Labeling

Label is not available on this site.

04/03/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-15 Labeling

Label is not available on this site.

06/16/1989 SUPPL-13 Labeling

Label is not available on this site.

12/08/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/01/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/22/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/22/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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