Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020124
Company: US ARMY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
12/05/1990 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
12/16/2016 SUPPL-32 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020124s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020124Orig1s032ltr.pdf
10/31/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/07/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/25/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/23/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/15/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/11/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/11/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/24/1992 SUPPL-1 Manufacturing (CMC)-Formulation

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-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020124s032lbl.pdf
12/16/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020124s032lbl.pdf

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