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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020124
Company: US ARMY

Products on NDA 020124

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DIAZEPAM	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020124

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
01/13/2023	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020124s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020124Orig1s034ltr.pdf
02/05/2021	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020124s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020124Orig1s033ltr.pdf
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.

Labels for NDA 020124

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020124s034lbl.pdf
02/05/2021	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020124s033lbl.pdf
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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