Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214272
Company: ABON PHARMS LLC

Products on ANDA 214272

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214272

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214272

ATOVAQUONE

SUSPENSION;ORAL; 750MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	210510	ABHAI LLC
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	214272	ABON PHARMS LLC
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	202960	AMNEAL PHARMS
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209750	APOTEX
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	212918	BIONPHARMA
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	207833	CHARTWELL RX
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209685	GLENMARK PHARMS
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	210692	HETERO LABS LTD III
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209105	LUPIN LTD
MEPRON	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	020500	GLAXOSMITHKLINE LLC