Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084217
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROTHIAZIDE CHLOROTHIAZIDE 500MG TABLET;ORAL Prescription None No No
CHLOROTHIAZIDE CHLOROTHIAZIDE 250MG TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/17/1975 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
04/04/2005 SUPPL-198 Labeling

Label is not available on this site.

02/14/2001 SUPPL-196 Labeling

Label is not available on this site.

01/25/2001 SUPPL-195 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1998 SUPPL-194 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-193 Manufacturing (CMC)

Label is not available on this site.

02/12/1996 SUPPL-192 Labeling

Label is not available on this site.

03/11/1994 SUPPL-191 Labeling

Label is not available on this site.

02/22/1994 SUPPL-190 Manufacturing (CMC)

Label is not available on this site.

03/01/1993 SUPPL-188 Labeling

Label is not available on this site.

12/06/1989 SUPPL-187 Labeling

Label is not available on this site.

01/31/1990 SUPPL-185 Manufacturing (CMC)

Label is not available on this site.

11/10/1987 SUPPL-183 Manufacturing (CMC)

Label is not available on this site.

09/18/1984 SUPPL-179 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-178 Manufacturing (CMC)

Label is not available on this site.

03/26/1982 SUPPL-177 Manufacturing (CMC)

Label is not available on this site.

07/13/1989 SUPPL-88 Bioequivalence

Label is not available on this site.

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