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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211969
Company: UMEDICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFINACONAZOLE EFINACONAZOLE 10% SOLUTION;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
06/21/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2024 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

EFINACONAZOLE

SOLUTION;TOPICAL; 10%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFINACONAZOLE EFINACONAZOLE 10% SOLUTION;TOPICAL Prescription No AB 211827 TEVA PHARMS USA
EFINACONAZOLE EFINACONAZOLE 10% SOLUTION;TOPICAL Prescription No AB 211969 UMEDICA
JUBLIA EFINACONAZOLE 10% SOLUTION;TOPICAL Prescription Yes AB 203567 BAUSCH
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