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Abbreviated New Drug Application (ANDA): 205971
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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2025 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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
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