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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211303
Company: ENCUBE ETHICALS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERMETHRIN PERMETHRIN 5% 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
04/03/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

PERMETHRIN

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERMETHRIN PERMETHRIN 5% CREAM;TOPICAL Prescription No AB 074806 ACTAVIS LABS
PERMETHRIN PERMETHRIN 5% CREAM;TOPICAL Prescription No AB 211303 ENCUBE ETHICALS
PERMETHRIN PERMETHRIN 5% CREAM;TOPICAL Prescription No AB 076369 PADAGIS ISRAEL
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