Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204708
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIRVASO | BRIMONIDINE TARTRATE | EQ 0.33% BASE | 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 |
---|---|---|---|---|---|---|---|
08/23/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204708lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204708Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/27/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204708s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204708Orig1s005ltr.pdf | |
09/23/2015 | SUPPL-3 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204708s003lbl.pdf | |
03/03/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/05/2014 | 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 |
---|---|---|---|---|---|
07/27/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204708s005lbl.pdf | |
09/23/2015 | SUPPL-3 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204708s003lbl.pdf |
08/23/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204708lbl.pdf |
MIRVASO
GEL;TOPICAL; EQ 0.33% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | EQ 0.33% BASE | GEL;TOPICAL | Prescription | No | AB | 209158 | PADAGIS ISRAEL |
MIRVASO | BRIMONIDINE TARTRATE | EQ 0.33% BASE | GEL;TOPICAL | Prescription | Yes | AB | 204708 | GALDERMA LABS LP |