Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087689
Company: ANI PHARMS INC
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
09/16/1981 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
09/14/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-20 Labeling

Label is not available on this site.

01/28/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/12/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/11/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/11/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/02/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/02/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/02/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/09/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/09/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/12/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/29/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/30/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/23/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/28/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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