Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021794
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACZONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/07/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021794ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021794s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/18/2018 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021794Orig1s016ltr.pdf | |
09/03/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/09/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021794Orig1s013ltr.pdf | |
11/08/2013 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/03/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/26/2009 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
03/14/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021794s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/18/2018 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf | |
05/18/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf | |
07/09/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf | |
03/26/2009 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
03/26/2009 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
03/14/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf | |
07/07/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf |
ACZONE
GEL;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACZONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | Yes | AB | 021794 | ABBVIE |
DAPSONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | No | AB | 209890 | AMNEAL |
DAPSONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | No | AB | 210178 | COSETTE |
DAPSONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | No | AB | 212383 | ENCUBE |
DAPSONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | No | AB | 209506 | TARO |
DAPSONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | No | AB | 213907 | TRUPHARMA |