Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209158
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | EQ 0.33% BASE | GEL;TOPICAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/23/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209158Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/09/2022 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
BRIMONIDINE TARTRATE
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 |