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Abbreviated New Drug Application (ANDA): 211827
Company: TEVA PHARMS USA

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
12/16/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211827Orig1s000ltr.pdf

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 211969 NIVAGEN PHARMS INC
EFINACONAZOLE EFINACONAZOLE 10% SOLUTION;TOPICAL Prescription No AB 211827 TEVA PHARMS USA
JUBLIA EFINACONAZOLE 10% SOLUTION;TOPICAL Prescription Yes AB 203567 BAUSCH
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