Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202362

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ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (ATOVAQUONE; PROGUANIL HYDROCHLORIDE)
62.5MG;25MG
Marketing Status: Prescription
Active Ingredient: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Proprietary Name: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 62.5MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202362
Product Number: 001
Approval Date: May 27, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (ATOVAQUONE; PROGUANIL HYDROCHLORIDE)
250MG;100MG
Marketing Status: Prescription
Active Ingredient: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Proprietary Name: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202362
Product Number: 002
Approval Date: May 27, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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