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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212714
Company: ALKEM LABS LTD

Products on ANDA 212714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	AB	No	No
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	AB	No	No
CLOBAZAM	CLOBAZAM	5MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2019	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
05/01/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/01/2023	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212714

CLOBAZAM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	212714	ALKEM LABS LTD
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	209718	AMNEAL PHARMS CO
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	208825	BIONPHARMA
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	209308	BRECKENRIDGE
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	209795	HETERO LABS LTD III
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	210545	LUPIN LTD
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	211711	MICRO LABS
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	213404	MSN
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	209808	PIRAMAL HLTHCARE UK
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	209687	UPSHER SMITH LABS
CLOBAZAM	CLOBAZAM	10MG	TABLET;ORAL	Prescription	No	AB	211449	ZYDUS PHARMS
ONFI	CLOBAZAM	10MG	TABLET;ORAL	Prescription	Yes	AB	202067	LUNDBECK PHARMS LLC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	212714	ALKEM LABS LTD
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	209718	AMNEAL PHARMS CO
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	208825	BIONPHARMA
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	209795	HETERO LABS LTD III
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	210545	LUPIN LTD
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	211711	MICRO LABS
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	213404	MSN
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	209808	PIRAMAL HLTHCARE UK
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	209687	UPSHER SMITH LABS
CLOBAZAM	CLOBAZAM	20MG	TABLET;ORAL	Prescription	No	AB	211449	ZYDUS PHARMS
ONFI	CLOBAZAM	20MG	TABLET;ORAL	Prescription	Yes	AB	202067	LUNDBECK PHARMS LLC

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