Details for New Drug Application (NDA): 020944
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NDA 020944 describes JUNIOR STRENGTH ADVIL, which is a drug marketed by Haleon Us Holdings and is included in two NDAs. It is available from three suppliers. Additional details are available on the JUNIOR STRENGTH ADVIL profile page.
The generic ingredient in JUNIOR STRENGTH ADVIL is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and thirty-eight suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
The generic ingredient in JUNIOR STRENGTH ADVIL is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and thirty-eight suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020944
| Tradename: | JUNIOR STRENGTH ADVIL |
| Applicant: | Haleon Us Holdings |
| Ingredient: | ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 020944
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 020944
Suppliers and Packaging for NDA: 020944
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | ibuprofen | TABLET, CHEWABLE;ORAL | 020944 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0573-0179 | 0573-0179-20 | 1 BOTTLE in 1 CARTON (0573-0179-20) / 24 TABLET, CHEWABLE in 1 BOTTLE |
| CHILDREN'S ADVIL | ibuprofen | TABLET, CHEWABLE;ORAL | 020944 | NDA | Proficient Rx LP | 71205-425 | 71205-425-24 | 1 BOTTLE in 1 CARTON (71205-425-24) / 24 TABLET, CHEWABLE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 18, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 18, 1998 | TE: | RLD: | No | |||||
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