Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210692
Company: HETERO LABS LTD III

Products on ANDA 210692

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 210692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2026	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/02/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210692

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	202960	AMNEAL PHARMS
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 SPECLT
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	210692	HETERO LABS LTD III
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	214272	PAI HOLDINGS
MEPRON	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	020500	GLAXOSMITHKLINE LLC