Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212215
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
05/07/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212215Orig1s000TAltr.pdf |
TAVABOROLE
SOLUTION;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 212188 | ALEMBIC |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 212256 | AMNEAL |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 211963 | CHARTWELL RX |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 212224 | CIPLA |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 211297 | ENCUBE |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 212168 | LUPIN LTD |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 211848 | PADAGIS US |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 212215 | TARO |
TAVABOROLE | TAVABOROLE | 5% | SOLUTION;TOPICAL | Prescription | No | AB | 212294 | ZYDUS LIFESCIENCES |