Details for New Drug Application (NDA): 017463
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NDA 017463 describes MOTRIN, which is a drug marketed by Mcneil, Mcneil Consumer, Mcneil Ped, and Kenvue Brands, and is included in six NDAs. Additional details are available on the MOTRIN profile page.
The generic ingredient in MOTRIN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-six suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
The generic ingredient in MOTRIN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-six suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 017463
| Tradename: | MOTRIN |
| Applicant: | Mcneil Consumer |
| Ingredient: | ibuprofen |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017463
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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