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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085022
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 100MG TABLET;ORAL Discontinued None Yes 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
09/01/1977 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-33 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

11/15/2002 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/22/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

04/30/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/13/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/17/1995 SUPPL-18 Labeling

Label is not available on this site.

03/12/1993 SUPPL-17 Labeling

Label is not available on this site.

10/06/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/07/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/07/1993 SUPPL-14 Labeling

Label is not available on this site.

02/25/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-1 Bioequivalence

Label is not available on this site.

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