Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016721
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DALMANE FLURAZEPAM HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
DALMANE FLURAZEPAM HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
04/07/1970 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2009 SUPPL-77 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016721s077ltr.pdf
10/30/2007 SUPPL-76 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016721s076,s058ltr.pdf
08/12/2002 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/14/2001 SUPPL-74 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16721s74ltr.pdf
05/25/1993 SUPPL-72 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/31/1992 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1990 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1990 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

11/07/1989 SUPPL-67 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/09/1987 SUPPL-66 Labeling

Label is not available on this site.

12/11/1984 SUPPL-64 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/15/1982 SUPPL-63 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/28/1982 SUPPL-62 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1981 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1981 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1981 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

08/04/1981 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/17/1981 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1981 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1981 SUPPL-54 Labeling

Label is not available on this site.

08/20/1980 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1980 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1980 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1980 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/17/1980 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1980 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/09/1979 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/17/1979 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/01/1979 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/26/1979 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/28/1978 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/12/1978 SUPPL-41 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/20/1978 SUPPL-40 Labeling

Label is not available on this site.

07/10/1978 SUPPL-39 Labeling

Label is not available on this site.

05/02/1978 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/12/1977 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/29/1977 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1977 SUPPL-34 Labeling

Label is not available on this site.

12/10/1976 SUPPL-32 Labeling

Label is not available on this site.

07/10/1978 SUPPL-30 Labeling

Label is not available on this site.

07/01/1975 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1975 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1974 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1974 SUPPL-23 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/27/2009 SUPPL-77 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
10/30/2007 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf

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