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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202385
Company: AMNEAL PHARMS

Products on ANDA 202385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202385s000ltr.pdf

Therapeutic Equivalents for ANDA 202385

FELBAMATE

SUSPENSION;ORAL; 600MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	202385	AMNEAL PHARMS
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	211333	NOVITIUM PHARMA
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	206314	TARO
FELBATOL	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	020189	MYLAN SPECIALITY LP

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