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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202362
Company: MYLAN

Products on ANDA 202362

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET;ORAL	Prescription	AB	No	No
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202362

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2014	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
11/22/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202362

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

TABLET;ORAL; 62.5MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET;ORAL	Prescription	No	AB	091211	GLENMARK PHARMS LTD
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET;ORAL	Prescription	No	AB	202362	MYLAN
MALARONE PEDIATRIC	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET;ORAL	Prescription	Yes	AB	021078	GLAXOSMITHKLINE

TABLET;ORAL; 250MG;100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET;ORAL	Prescription	No	AB	091211	GLENMARK PHARMS LTD
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET;ORAL	Prescription	No	AB	202362	MYLAN
MALARONE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET;ORAL	Prescription	Yes	AB	021078	GLAXOSMITHKLINE

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