Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210019
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IVERMECTIN IVERMECTIN 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
09/13/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210019Orig1s000TA_ltr.pdf

IVERMECTIN

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IVERMECTIN IVERMECTIN 1% CREAM;TOPICAL Prescription No AB 210019 TEVA PHARMS USA
SOOLANTRA IVERMECTIN 1% CREAM;TOPICAL Prescription Yes AB 206255 GALDERMA LABS LP

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