An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210363
Company: BELOTECA

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-Container/Carton Labels, Labeling-Package Insert		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	210363	BELOTECA
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

Top