Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212428
Company: CHARTWELL RX

Products on ANDA 212428

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212428

OXCARBAZEPINE

SUSPENSION;ORAL; 300MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	213183	ALKEM LABS LTD
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	202961	AMNEAL PHARMS
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215332	AUCTA
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	218278	BIOCON PHARMA
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209652	BIONPHARMA
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	212428	CHARTWELL RX
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	216749	HETERO LABS LTD III
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	217782	MEDLEY PHARMS
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215726	RUBICON
OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	078734	SUN PHARM INDS LTD
TRILEPTAL	OXCARBAZEPINE	300MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	021285	NOVARTIS