Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087118
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORTHALIDONE CHLORTHALIDONE 50MG 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
09/16/1994 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
03/27/1991 SUPPL-21 Bioequivalence

Label is not available on this site.

04/18/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/18/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/23/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/08/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/03/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/23/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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