Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091076
Company: NOVEL LABS INC

Products on ANDA 091076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	GEL;RECTAL	Prescription	AB	No	No
DIAZEPAM	DIAZEPAM	20MG/4ML (5MG/ML)	GEL;RECTAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091076

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2023	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/091076Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2024	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091076

DIAZEPAM

GEL;RECTAL; 10MG/2ML (5MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIASTAT ACUDIAL	DIAZEPAM	10MG/2ML (5MG/ML)	GEL;RECTAL	Prescription	Yes	AB	020648	BAUSCH
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	GEL;RECTAL	Prescription	No	AB	091076	NOVEL LABS INC

GEL;RECTAL; 20MG/4ML (5MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIASTAT ACUDIAL	DIAZEPAM	20MG/4ML (5MG/ML)	GEL;RECTAL	Prescription	Yes	AB	020648	BAUSCH
DIAZEPAM	DIAZEPAM	20MG/4ML (5MG/ML)	GEL;RECTAL	Prescription	No	AB	091076	NOVEL LABS INC