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 Over-the-counter None 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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2021 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

IVERMECTIN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

LOTION;TOPICAL; 0.5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IVERMECTIN IVERMECTIN 0.5% LOTION;TOPICAL Over-the-counter No 210720 TARO
SKLICE IVERMECTIN 0.5% LOTION;TOPICAL Over-the-counter Yes 202736 ARBOR PHARMS LLC

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