Drugs@FDA: FDA-Approved Drugs
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-Package Insert, Labeling-Container/Carton Labels |
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. |
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12/09/1998 | SUPPL-31 | Labeling |
Label is not available on this site. |
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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. |
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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. |
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11/04/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
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08/28/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
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03/06/1984 | SUPPL-20 | Labeling |
Label is not available on this site. |
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05/08/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
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01/13/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
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10/31/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/13/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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10/31/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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10/31/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
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07/31/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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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 |