Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016087
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALIUM DIAZEPAM 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
08/24/1966 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
09/04/1998 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1997 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1997 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

02/07/2002 SUPPL-81 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf
05/25/1993 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/2002 SUPPL-79 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf
04/23/1987 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1987 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1986 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1986 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1986 SUPPL-72 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/15/1986 SUPPL-71 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/06/1985 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

06/27/1985 SUPPL-69 Labeling

Label is not available on this site.

05/31/1985 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

06/26/1985 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1985 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1983 SUPPL-63 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1983 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1983 SUPPL-61 Labeling

Label is not available on this site.

03/14/1983 SUPPL-60 Labeling

Label is not available on this site.

03/14/1983 SUPPL-59 Labeling

Label is not available on this site.

04/06/1983 SUPPL-58 Labeling

Label is not available on this site.

03/01/1983 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

10/29/1982 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1982 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1982 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

05/18/1982 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1982 SUPPL-51 Labeling

Label is not available on this site.

11/19/1981 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1981 SUPPL-49 Labeling

Label is not available on this site.

11/13/1981 SUPPL-48 Labeling

Label is not available on this site.

08/24/1981 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1981 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1981 SUPPL-45 Labeling

Label is not available on this site.

04/16/1981 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/20/1981 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/19/1980 SUPPL-42 Labeling

Label is not available on this site.

07/20/1979 SUPPL-41 Labeling

Label is not available on this site.

11/02/1979 SUPPL-40 Labeling

Label is not available on this site.

05/31/1979 SUPPL-39 Labeling

Label is not available on this site.

04/09/1979 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/23/1979 SUPPL-37 Labeling

Label is not available on this site.

03/15/1980 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1978 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1977 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1976 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/23/1976 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1975 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1974 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1974 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1974 SUPPL-23 Labeling

Label is not available on this site.

06/20/1974 SUPPL-22 Labeling

Label is not available on this site.

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