Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078837
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMIQUIMOD IMIQUIMOD 5% 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
09/07/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

IMIQUIMOD

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALDARA IMIQUIMOD 5% CREAM;TOPICAL Prescription Yes AB 020723 MEDICIS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 091044 ANDA REPOSITORY
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 091308 APOTEX INC
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 078548 FOUGERA PHARMS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 201994 GLENMARK GENERICS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 078837 PERRIGO ISRAEL
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 200173 TARO

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