Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088903
Company: BARR LABS 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
09/19/1985 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
05/17/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

11/20/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/05/1995 SUPPL-13 Labeling

Label is not available on this site.

05/11/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/08/1992 SUPPL-11 Labeling

Label is not available on this site.

02/05/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/05/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/18/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/24/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/24/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/01/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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