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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211998
Company: BELOTECA

Products on ANDA 211998

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211998

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211998Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/10/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211998s006lbl.pdf
05/21/2021	SUPPL-4	Labeling-Patient Package Insert		Label is not available on this site.
05/21/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 211998

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211998s006lbl.pdf

Therapeutic Equivalents for ANDA 211998

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

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