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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211199
Company: ALKEM LABS LTD

Products on ANDA 211199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	AB	No	No
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	AB	No	No
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	AB	No	No
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211199

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211199

ESLICARBAZEPINE ACETATE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211236	APOTEX
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211246	LUPIN LTD

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211236	APOTEX
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211246	LUPIN LTD

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211236	APOTEX
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211246	LUPIN LTD

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211236	APOTEX
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211246	LUPIN LTD

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