Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073191
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;50MG CAPSULE;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
07/31/1991 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
04/18/2012 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

08/13/2008 SUPPL-27 Labeling

Label is not available on this site.

01/05/2004 SUPPL-20 Labeling

Label is not available on this site.

04/19/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1999 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/14/1999 SUPPL-11 Labeling

Label is not available on this site.

04/14/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/13/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/13/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/06/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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