Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021381
Company: DENTSPLY PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE DENTAL WITH EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;2% INJECTABLE;INJECTION Discontinued None No No
XYLOCAINE DENTAL WITH EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.02MG/ML;2% 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
11/19/1948 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-6 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021381s006lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021381s006lbl.pdf

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