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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210364
Company: AUROBINDO PHARMA USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;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
04/18/2018 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
06/08/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ECONAZOLE NITRATE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription No AB 210364 AUROBINDO PHARMA USA
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription No AB 076479 PADAGIS ISRAEL
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription No AB 076005 SUN PHARMA CANADA
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