Details for New Drug Application (NDA): 020500

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NDA 020500 describes MEPRON, which is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the MEPRON profile page.

The generic ingredient in MEPRON is atovaquone. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the atovaquone profile page.

Summary for 020500

Tradename:	MEPRON
Applicant:	Glaxosmithkline Llc
Ingredient:	atovaquone
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020500

Medical Subject Heading (MeSH) Categories for 020500

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Suppliers and Packaging for NDA: 020500

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEPRON	atovaquone	SUSPENSION;ORAL	020500	NDA	GlaxoSmithKline LLC	0173-0547	0173-0547-00	42 POUCH in 1 DOSE PACK (0173-0547-00) > 5 mL in 1 POUCH
MEPRON	atovaquone	SUSPENSION;ORAL	020500	NDA	GlaxoSmithKline LLC	0173-0665	0173-0665-18	210 mL in 1 BOTTLE (0173-0665-18)

Paragraph IV (Patent) Challenges for 020500

Tradename	Dosage	Ingredient	NDA	Submissiondate
MEPRON	SUSPENSION;ORAL	atovaquone	020500	2009-10-20

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Feb 8, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020500

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	Start Trial	Start Trial
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	Start Trial	Start Trial
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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