Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200744
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TACROLIMUS TACROLIMUS 0.03% OINTMENT;TOPICAL Prescription AB No No
TACROLIMUS TACROLIMUS 0.1% OINTMENT;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
09/09/2014 ORIG-1 Approval Not Applicable Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200744Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/200744Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2015 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

TACROLIMUS

OINTMENT;TOPICAL; 0.03%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROTOPIC TACROLIMUS 0.03% OINTMENT;TOPICAL Prescription Yes AB 050777 LEO PHARMA AS
TACROLIMUS TACROLIMUS 0.03% OINTMENT;TOPICAL Prescription No AB 211688 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS 0.03% OINTMENT;TOPICAL Prescription No AB 200744 FOUGERA PHARMS INC

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROTOPIC TACROLIMUS 0.1% OINTMENT;TOPICAL Prescription Yes AB 050777 LEO PHARMA AS
TACROLIMUS TACROLIMUS 0.1% OINTMENT;TOPICAL Prescription No AB 211688 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS 0.1% OINTMENT;TOPICAL Prescription No AB 200744 FOUGERA PHARMS INC
TACROLIMUS TACROLIMUS 0.1% OINTMENT;TOPICAL Prescription No AB 210393 GLENMARK PHARMS LTD

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