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Details for New Drug Application (NDA): 020812
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NDA 020812 describes PEDIATRIC ADVIL, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the PEDIATRIC ADVIL profile page.
The generic ingredient in PEDIATRIC ADVIL is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and seven suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
The generic ingredient in PEDIATRIC ADVIL is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and seven suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020812
| Tradename: | PEDIATRIC ADVIL |
| Applicant: | Glaxosmithkline |
| Ingredient: | ibuprofen |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020812
Suppliers and Packaging for NDA: 020812
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INFANT'S ADVIL | ibuprofen | SUSPENSION/DROPS;ORAL | 020812 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0573-0191 | 0573-0191-20 | 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) > 15 mL in 1 BOTTLE, DROPPER |
| INFANT'S ADVIL | ibuprofen | SUSPENSION/DROPS;ORAL | 020812 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0573-0191 | 0573-0191-22 | 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) > 15 mL in 1 BOTTLE, DROPPER |
Paragraph IV (Patent) Challenges for 020812
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| INFANT'S ADVIL | SUSPENSION/DROPS;ORAL | ibuprofen | 020812 | 2007-06-29 |
| PEDIATRIC ADVIL | SUSPENSION/DROPS;ORAL | ibuprofen | 020812 | 2007-06-29 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION/DROPS;ORAL | Strength | 100MG/2.5ML | ||||
| Approval Date: | Jan 30, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION/DROPS;ORAL | Strength | 50MG/1.25ML | ||||
| Approval Date: | Jan 12, 2000 | TE: | RLD: | Yes | |||||
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