Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071325
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLORPRES CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE 15MG;0.3MG TABLET;ORAL Discontinued None No No
CLORPRES CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE 15MG;0.2MG TABLET;ORAL Discontinued None No No
CLORPRES CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE 15MG;0.1MG 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
02/09/1987 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
08/22/2002 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/11/1998 SUPPL-13 Labeling

Label is not available on this site.

12/10/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/16/1998 SUPPL-11 Labeling

Label is not available on this site.

02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/03/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/15/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/23/1989 SUPPL-5 Labeling

Label is not available on this site.

05/24/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/13/1988 SUPPL-3 Labeling

Label is not available on this site.

04/01/1988 SUPPL-2 Labeling

Label is not available on this site.

06/23/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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