Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072370
Company: WATSON LABS INC

Products on ANDA 072370

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1993	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/26/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/072370s009lbl.pdf
08/26/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/15/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-3	Labeling		Label is not available on this site.
08/15/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/23/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 072370

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/072370s009lbl.pdf