Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022483
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZYCLARA | IMIQUIMOD | 3.75% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
ZYCLARA | IMIQUIMOD | 2.5% | CREAM;TOPICAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
03/25/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022483s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483_zyclara_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/16/2024 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022483s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022483Orig1s011ltr.pdf | |
11/24/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/14/2012 | SUPPL-6 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022483s006ltr.pdf | |
07/15/2011 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s003ltr.pdf | |
09/29/2011 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s002ltr.pdf | |
03/24/2011 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/16/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022483s011lbl.pdf | |
09/16/2024 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022483s011lbl.pdf | |
02/14/2012 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf |
09/29/2011 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf | |
07/15/2011 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf | |
03/24/2011 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf | |
03/25/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf |
ZYCLARA
CREAM;TOPICAL; 3.75%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IMIQUIMOD | IMIQUIMOD | 3.75% | CREAM;TOPICAL | Prescription | No | AB | 205971 | TARO |
ZYCLARA | IMIQUIMOD | 3.75% | CREAM;TOPICAL | Prescription | Yes | AB | 022483 | BAUSCH |