Drugs@FDA: FDA-Approved Drugs

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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

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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