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Details for New Drug Application (NDA): 020589
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The generic ingredient in CHILDREN'S ADVIL-FLAVORED is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and six suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020589
Tradename: | CHILDREN'S ADVIL-FLAVORED |
Applicant: | Glaxosmithkline |
Ingredient: | ibuprofen |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020589
Suppliers and Packaging for NDA: 020589
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 020589 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0573-0170 | 0573-0170-01 | 1 BOTTLE in 1 CARTON (0573-0170-01) > 30 mL in 1 BOTTLE |
CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 020589 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0573-0170 | 0573-0170-30 | 1 BOTTLE in 1 CARTON (0573-0170-30) > 120 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Jun 27, 1996 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Nov 7, 1997 | TE: | RLD: | No | |||||
Patent: | Start Trial | Patent Expiration: | May 25, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 020589
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 020589-001 | Jun 27, 1996 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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