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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210821
Company: BAUSCH LOMB IRELAND
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE 0.5% SOLUTION;OPHTHALMIC Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/12/2019 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210821s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210821Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210821Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2022 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210821s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210821Orig1s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2022 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210821s005lbl.pdf
03/12/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210821s000lbl.pdf
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