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Details for New Drug Application (NDA): 020812
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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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