Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087706
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORTHALIDONE CHLORTHALIDONE 25MG 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-19 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-17 Labeling

Label is not available on this site.

01/28/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/24/1989 SUPPL-13 Labeling

Label is not available on this site.

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

Label is not available on this site.

04/13/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/13/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/29/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/11/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/29/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/30/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/25/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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