Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078548
Company: FOUGERA PHARMS

Products on ANDA 078548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2010	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078548s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078548Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/18/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/18/2015	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078548

IMIQUIMOD

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	078548	FOUGERA PHARMS
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	201994	GLENMARK PHARMS
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	078837	PADAGIS ISRAEL
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	200173	TARO