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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207717
Company: RUBICON RESEARCH

Products on ANDA 207717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	AB	No	No
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	AB	No	No
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207717

OXCARBAZEPINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	078005	ANI PHARMS
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	215939	ANNORA PHARMA
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	078069	BRECKENRIDGE PHARM
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	219556	EPIC PHARMA LLC
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	077802	GLENMARK PHARMS LTD
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	077747	RUBICON RESEARCH
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	207717	RUBICON RESEARCH
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	077794	SUN PHARM INDS
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	077801	TARO
TRILEPTAL	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	Yes	AB	021014	NOVARTIS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	078005	ANI PHARMS
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	215939	ANNORA PHARMA
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	078069	BRECKENRIDGE PHARM
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	219556	EPIC PHARMA LLC
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	077802	GLENMARK PHARMS LTD
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	077747	RUBICON RESEARCH
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	207717	RUBICON RESEARCH
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	077794	SUN PHARM INDS
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	077801	TARO
TRILEPTAL	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	Yes	AB	021014	NOVARTIS

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	078005	ANI PHARMS
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	215939	ANNORA PHARMA
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	078069	BRECKENRIDGE PHARM
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	219556	EPIC PHARMA LLC
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	077802	GLENMARK PHARMS LTD
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	077747	RUBICON RESEARCH
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	207717	RUBICON RESEARCH
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	077794	SUN PHARM INDS
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	077801	TARO
TRILEPTAL	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	Yes	AB	021014	NOVARTIS

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