Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019833
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 09/19/1989 | 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 |
|---|---|---|---|---|---|
| 05/08/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1998 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-833S011.pdf |
| 10/24/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1994 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |