Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210720
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IVERMECTIN IVERMECTIN 0.5% LOTION;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
05/06/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210720Orig1s000ltr.pdf

IVERMECTIN

LOTION;TOPICAL; 0.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IVERMECTIN IVERMECTIN 0.5% LOTION;TOPICAL Prescription No AB 210720 TARO
SKLICE IVERMECTIN 0.5% LOTION;TOPICAL Prescription Yes AB 202736 ARBOR PHARMS LLC

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