Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205971
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMIQUIMOD | IMIQUIMOD | 3.75% | CREAM;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 |
---|---|---|---|---|---|---|---|
01/26/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205971Orig1s000ltr.pdf |
IMIQUIMOD
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 |