Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202961
Company: AMNEAL PHARMS

Products on ANDA 202961

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 202961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/01/2022	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/01/2022	SUPPL-5	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/01/2022	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/04/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/04/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202961

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