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Abbreviated New Drug Application (ANDA): 213584
Company: TARO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE 1% CREAM;TOPICAL Discontinued 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
10/04/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213584Orig1s000ltr.pdf
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