Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070311
Company: HIKMA

Products on ANDA 070311

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DIAZEPAM	DIAZEPAM	5MG/ML (5MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070311

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1985	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
01/17/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
11/12/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/070311s022lbl.pdf
05/17/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/21/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/16/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/17/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/08/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/18/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/22/1993	SUPPL-9	Labeling		Label is not available on this site.
02/01/1993	SUPPL-8	Labeling		Label is not available on this site.
09/07/1988	SUPPL-6	Labeling		Label is not available on this site.
02/26/1988	SUPPL-5	Labeling		Label is not available on this site.
11/03/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 070311

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/070311s022lbl.pdf

Therapeutic Equivalents for ANDA 070311

DIAZEPAM

INJECTABLE;INJECTION; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	211998	BELOTECA
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	070311	HIKMA
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	071583	HOSPIRA