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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216404
Company: RICONPHARMA LLC

Products on ANDA 216404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216404

CARBAMAZEPINE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212948	ANBISON LAB
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213159	APOTEX
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213311	CSPC OUYI
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216404	RICONPHARMA LLC
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216235	SCIECURE PHARMA INC
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078115	TARO
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216594	UMEDICA
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211623	UNIQUE PHARM
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215591	ZHEJIANG JIUZHOU
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205571	ZYDUS PHARMS
TEGRETOL-XR	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020234	NOVARTIS

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212948	ANBISON LAB
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213159	APOTEX
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213311	CSPC OUYI
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216404	RICONPHARMA LLC
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216235	SCIECURE PHARMA INC
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078115	TARO
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216594	UMEDICA
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211623	UNIQUE PHARM
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215591	ZHEJIANG JIUZHOU
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205571	ZYDUS PHARMS
TEGRETOL-XR	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020234	NOVARTIS

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212948	ANBISON LAB
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213159	APOTEX
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213311	CSPC OUYI
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216404	RICONPHARMA LLC
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216235	SCIECURE PHARMA INC
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078115	TARO
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216594	UMEDICA
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211623	UNIQUE PHARM
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215591	ZHEJIANG JIUZHOU
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205571	ZYDUS PHARMS
TEGRETOL-XR	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020234	NOVARTIS

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