Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088164
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
01/09/1984 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
07/29/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-9 Labeling

Label is not available on this site.

03/08/1993 SUPPL-8 Labeling

Label is not available on this site.

09/17/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/23/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/23/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/24/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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