Drugs@FDA: FDA-Approved Drugs
Company: MCNEIL CONSUMER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOTRIN | IBUPROFEN | 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/19/1989 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/10/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019842s020ltr.pdf | |
01/24/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019842s019ltr.pdf | |
05/14/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/18/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/04/2002 | SUPPL-13 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm |
02/22/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/07/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/23/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/23/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/23/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/13/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/24/1995 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
03/23/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/10/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf | |
01/24/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf |