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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210363
Company: REGCON HOLDINGS

Products on ANDA 210363

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2019	ORIG-1	Approval		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
01/11/2023	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
02/08/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/23/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210363s007lbl.pdf
06/23/2021	SUPPL-6	Labeling-Patient Package Insert		Label is not available on this site.
06/23/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/06/2019	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 210363

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210363s007lbl.pdf

Therapeutic Equivalents for ANDA 210363

DIAZEPAM

INJECTABLE;INJECTION; 10MG/2ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	218450	ALEMBIC
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	218422	DR REDDYS
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214745	FRESENIUS KABI USA
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	070313	HIKMA
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	072079	HOSPIRA
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	217178	LONG GROVE PHARMS
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210363	REGCON HOLDINGS

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