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Details for New Drug Application (NDA): 020500
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. Nine suppliers are listed for this compound. Additional details are available on the atovaquone profile page.
The generic ingredient in MEPRON is atovaquone. There are sixteen drug master file entries for this compound. Nine 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 |
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
| 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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