Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020135
Company: MCNEIL PED
Company: MCNEIL PED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOTRIN | IBUPROFEN | 50MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
MOTRIN | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
11/16/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
08/05/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/14/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/04/2002 | SUPPL-5 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm |
01/02/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/24/1995 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |