Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076359
Company: PERRIGO
Company: PERRIGO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 50MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
IBUPROFEN | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Over-the-counter | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/16/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76359ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/26/2012 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
01/21/2011 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
08/22/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
03/17/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
IBUPROFEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 100MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 076359 | PERRIGO |
JUNIOR STRENGTH ADVIL | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 020944 | HALEON US HOLDINGS |