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Generated: July 22, 2017

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Details for New Drug Application (NDA): 202362

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NDA 202362 describes ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, which is a drug marketed by Glenmark Generics and Mylan Pharms Inc and is included in two NDAs. It is available from ten suppliers. Additional details are available on the ATOVAQUONE AND PROGUANIL HYDROCHLORIDE profile page.

The generic ingredient in ATOVAQUONE AND PROGUANIL HYDROCHLORIDE is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.

Summary for NDA: 202362

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 202362

Suppliers and Packaging for NDA: 202362

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
atovaquone; proguanil hydrochloride
TABLET;ORAL 202362 ANDA Mylan Pharmaceuticals Inc. 0378-4160 0378-4160-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
atovaquone; proguanil hydrochloride
TABLET;ORAL 202362 ANDA Mylan Pharmaceuticals Inc. 0378-4160 0378-4160-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength62.5MG;25MG
Approval Date:May 27, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG;100MG
Approval Date:May 27, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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