Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213039
Company: ALKEM LABS LTD

Products on ANDA 213039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2021	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
02/19/2025	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/26/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213039

CLOBAZAM

SUSPENSION;ORAL; 2.5MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	213039	ALKEM LABS LTD
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210039	AMNEAL
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	214404	AUROBINDO PHARMA LTD
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	208819	BIONPHARMA
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	213110	CHARTWELL MOLECULAR
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	209796	HETERO LABS LTD III
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210978	TARO
ONFI	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	203993	LUNDBECK PHARMS LLC