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 J And J Consumer Inc, 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 thirty-nine 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 thirty-nine 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DISCN | Dosage: | TABLET;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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DISCN | Dosage: | TABLET;ORAL | Strength | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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