Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210393
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
04/16/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

TACROLIMUS

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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