Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020941
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ABREVA | DOCOSANOL | 10% | CREAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
07/25/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20941ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-941_Abreva.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/10/2017 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020941Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020941Orig1s012ltr.pdf | |
01/30/2015 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020941Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020941Orig1s011ltr.pdf | |
02/08/2008 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020941s009ltr.pdf |
05/23/2007 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020941s006ltr.pdf | |
12/13/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/18/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/12/2001 | 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 |
---|---|---|---|---|---|
01/10/2017 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020941Orig1s012lbl.pdf | |
01/30/2015 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020941Orig1s011lbl.pdf | |
05/23/2007 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf | |
05/23/2007 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf | |
07/25/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf |
ABREVA
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;TOPICAL; 10%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ABREVA | DOCOSANOL | 10% | CREAM;TOPICAL | Over-the-counter | Yes | 020941 | HALEON US HOLDINGS |
DOCOSANOL | DOCOSANOL | 10% | CREAM;TOPICAL | Over-the-counter | No | 215839 | ALEMBIC |
DOCOSANOL | DOCOSANOL | 10% | CREAM;TOPICAL | Over-the-counter | No | 217090 | AUROBINDO PHARMA LTD |
DOCOSANOL | DOCOSANOL | 10% | CREAM;TOPICAL | Over-the-counter | No | 208754 | P AND L |
DOCOSANOL | DOCOSANOL | 10% | CREAM;TOPICAL | Over-the-counter | No | 212385 | P AND L DEVELOPMENT |
DOCOSANOL | DOCOSANOL | 10% | CREAM;TOPICAL | Over-the-counter | No | 214454 | TARO |