Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019771
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/19/1989 | 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 |
|---|---|---|---|---|---|
| 11/19/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019771orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019771Orig1s045ltr.pdf | |
| 03/23/2017 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019771Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019771Orig1s040ltr.pdf | |
| 09/02/2010 | SUPPL-36 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019771s036ltr.pdf |
| 05/19/2009 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019771s032ltr.pdf |
| 06/20/2008 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019771s031ltr.pdf |
| 02/23/2006 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s028ltr.pdf |
| 04/17/2006 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s026ltr.pdf |
| 10/17/2003 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19771slr022ltr.pdf |
| 08/02/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/2001 | SUPPL-20 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19771S20lbl.pdf | |
| 05/14/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/18/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/01/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/1994 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/04/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/15/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/17/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1994 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/19/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019771orig1s045lbl.pdf | |
| 03/23/2017 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019771Orig1s040lbl.pdf | |
| 05/23/2001 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19771S20lbl.pdf |
ADVIL COLD AND SINUS
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 |