Drugs@FDA: FDA-Approved Drugs
Company: J AND J CONSUMER INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SINE-AID IB | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | 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 |
---|---|---|---|---|---|---|---|
12/31/1992 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
---|---|---|---|---|---|
12/01/2021 | SUPPL-20 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019899Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019899Orig1s020ltr.pdf | |
05/15/2017 | SUPPL-19 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019899Orig1s019ltr.pdf | |
02/27/2006 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019899s018ltr.pdf |
07/29/2003 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19899slr015ltr.pdf | |
05/02/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/03/2002 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf |
09/03/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf |
11/29/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/06/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/03/2002 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf |
06/14/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/29/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/13/1993 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/01/2021 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019899Orig1s020lbl.pdf | |
05/15/2017 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf | |
07/29/2003 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf |
SINE-AID IB
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG;30MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | Yes | 019771 | HALEON US HOLDINGS |
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | No | 077628 | DR REDDYS LABS LTD |
IBUPROHM COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | No | 074567 | OHM LABS |
SINE-AID IB | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | No | 019899 | J AND J CONSUMER INC |