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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076574
Company: ENCUBE

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
12/17/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076574_ORIGINAL APPROVAL_PACKAGE.pdf

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 076574 ENCUBE
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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