Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201820
Company: CHIESI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETHKIS TOBRAMYCIN 300MG/4ML SOLUTION;INHALATION Prescription AN 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
10/12/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201820s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201820Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820_bethkis_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/09/2019 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201820s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201820Orig1s005ltr.pdf
05/29/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201820s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201820Orig1s003ltr.pdf
02/16/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/09/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201820s005lbl.pdf
05/29/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201820s003lbl.pdf
10/12/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201820s000lbl.pdf

BETHKIS

SOLUTION;INHALATION; 300MG/4ML
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETHKIS TOBRAMYCIN 300MG/4ML SOLUTION;INHALATION Prescription Yes AN 201820 CHIESI
TOBRAMYCIN TOBRAMYCIN 300MG/4ML SOLUTION;INHALATION Prescription No AN 210915 TEVA PHARMS USA

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