Drugs@FDA: FDA-Approved Drugs
Company: HALEON US HOLDINGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
JUNIOR STRENGTH ADVIL | IBUPROFEN | 100MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/13/1996 | 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 |
---|---|---|---|---|---|
03/29/2017 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020267Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020267Orig1s015ltr.pdf | |
05/19/2009 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020267s013ltr.pdf |
06/20/2008 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020267s012ltr.pdf |
01/17/2006 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020267s010ltr.pdf |
08/30/2004 | SUPPL-9 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20267s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020267Orig1s009.pdf |
08/02/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/23/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/14/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/30/1998 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/20/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2017 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020267Orig1s015lbl.pdf |
JUNIOR STRENGTH ADVIL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 100MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
JUNIOR STRENGTH ADVIL | IBUPROFEN | 100MG | TABLET;ORAL | Over-the-counter | No | 020267 | HALEON US HOLDINGS |
JUNIOR STRENGTH MOTRIN | IBUPROFEN | 100MG | TABLET;ORAL | Over-the-counter | No | 020602 | J AND J CONSUMER INC |