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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091211
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET;ORAL Prescription AB No No
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/12/2011 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-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/04/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

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 GENERICS
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

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 GENERICS
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
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