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Details for New Drug Application (NDA): 020589
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NDA 020589 describes CHILDREN'S ADVIL-FLAVORED, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CHILDREN'S ADVIL-FLAVORED profile page.
The generic ingredient in CHILDREN'S ADVIL-FLAVORED is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and fifty-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
The generic ingredient in CHILDREN'S ADVIL-FLAVORED is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and fifty-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020589
| Tradename: | CHILDREN'S ADVIL-FLAVORED |
| Applicant: | Pfizer |
| 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 | Wyeth Consumer Healthcare 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 | Wyeth Consumer Healthcare 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 |
|---|---|---|---|---|---|---|---|
| Pfizer | 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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