Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011870
Company: SALIX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIURIL CHLOROTHIAZIDE 250MG/5ML SUSPENSION;ORAL Prescription None Yes 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
10/06/1961 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2009 SUPPL-41 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/10/2009 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011870s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011870s040ltr.pdf
08/06/2007 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011870s039ltr.pdf
08/10/2005 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf
09/23/2004 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf
09/26/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2001 SUPPL-33 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/25/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-31 Labeling

Label is not available on this site.

05/23/1995 SUPPL-30 Labeling

Label is not available on this site.

02/16/1994 SUPPL-29 Labeling

Label is not available on this site.

03/02/1993 SUPPL-27 Labeling

Label is not available on this site.

01/13/1986 SUPPL-23 Labeling

Label is not available on this site.

11/04/1985 SUPPL-22 Labeling

Label is not available on this site.

08/28/1984 SUPPL-21 Labeling

Label is not available on this site.

03/06/1984 SUPPL-20 Labeling

Label is not available on this site.

05/08/1987 SUPPL-19 Labeling

Label is not available on this site.

01/13/1981 SUPPL-18 Labeling

Label is not available on this site.

10/31/1979 SUPPL-17 Labeling

Label is not available on this site.

07/13/1979 SUPPL-16 Labeling

Label is not available on this site.

10/31/1979 SUPPL-15 Labeling

Label is not available on this site.

10/31/1979 SUPPL-14 Labeling

Label is not available on this site.

07/31/1978 SUPPL-13 Labeling

Label is not available on this site.

03/27/1975 SUPPL-6 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2009 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011870s040lbl.pdf

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