Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201751
Company: HANSAMED INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTACAN ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) INJECTABLE;INJECTION 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
07/11/2017 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201751Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201751Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/11/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201751Orig1s000lbl.pdf

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