Drugs@FDA: FDA-Approved Drugs
Company: P AND L
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
04/30/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74916ta.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/13/2015 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
03/03/2015 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2014 | SUPPL-47 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/26/2012 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
05/13/2010 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
11/28/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
11/28/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
11/28/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
11/28/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
10/25/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/25/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
01/29/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/29/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/13/1999 | SUPPL-1 | 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.
SUSPENSION;ORAL; 100MG/5ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074937 | PERRIGO |
CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 020516 | J AND J CONSUMER INC |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210602 | APTAPHARMA INC |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209179 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210149 | GUARDIAN DRUG |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074916 | P AND L |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209207 | TARO |