Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013263
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALIUM DIAZEPAM 2MG TABLET;ORAL Prescription AB Yes No
VALIUM DIAZEPAM 5MG TABLET;ORAL Prescription AB Yes No
VALIUM DIAZEPAM 10MG TABLET;ORAL Prescription AB 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
11/15/1963 ORIG-1 Approval Type 1 - New Molecular Entity 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
12/16/2016 SUPPL-94 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013263Orig1s094ltr.pdf
07/30/2015 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

10/22/2013 SUPPL-92 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/013263Orig1s092ltr.pdf
04/19/2013 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

02/12/2002 SUPPL-86 Manufacturing (CMC)-Control Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13263s86ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf
11/08/2001 SUPPL-85 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/2001 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

05/12/2008 SUPPL-83 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf
05/09/2001 SUPPL-82 Manufacturing (CMC) Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13263s82ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013263_S082_Valium_APPROVAL PACKAGE.pdf
08/30/2000 SUPPL-81 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf
05/12/2008 SUPPL-80 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf
09/04/1998 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1997 SUPPL-78 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1997 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/2002 SUPPL-75 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf
10/26/1989 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

11/08/1988 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

02/07/2002 SUPPL-72 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S072_VALIUM_AP.pdf
01/20/1988 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1986 SUPPL-70 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/16/1985 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1984 SUPPL-67 Labeling

Label is not available on this site.

01/20/1983 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/1983 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1982 SUPPL-64 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/30/1982 SUPPL-63 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1982 SUPPL-62 Labeling

Label is not available on this site.

10/18/1982 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1982 SUPPL-60 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1982 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1982 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1982 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1983 SUPPL-55 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/26/1981 SUPPL-54 Labeling

Label is not available on this site.

07/17/1981 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

10/14/1980 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1980 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/19/1980 SUPPL-49 Labeling

Label is not available on this site.

01/09/1981 SUPPL-48 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/20/1979 SUPPL-47 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/02/1979 SUPPL-46 Labeling

Label is not available on this site.

04/04/1979 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1980 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1978 SUPPL-43 Labeling

Label is not available on this site.

09/21/1977 SUPPL-42 Labeling

Label is not available on this site.

12/14/1976 SUPPL-41 Labeling

Label is not available on this site.

10/27/1976 SUPPL-40 Labeling

Label is not available on this site.

08/27/1976 SUPPL-39 Labeling

Label is not available on this site.

08/25/1975 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1975 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1975 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1974 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-94 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf
12/16/2016 SUPPL-94 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf
10/22/2013 SUPPL-92 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf
05/12/2008 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf

VALIUM

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 070152 BARR
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 071307 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 071134 MAYNE PHARMA
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 2MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 071321 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 071135 MAYNE PHARMA
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 5MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 070154 BARR
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 071322 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 071136 MAYNE PHARMA
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 10MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

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