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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087176
Company: IVAX PHARMS
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
04/13/1981 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
07/29/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

07/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/26/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/26/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/26/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-15 Labeling

Label is not available on this site.

03/08/1993 SUPPL-14 Labeling

Label is not available on this site.

02/05/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/05/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/10/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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