Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205433
Company: PULMOFLOW INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KITABIS PAK TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription AN 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
12/02/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205433Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2019 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205433s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205433Orig1s005ltr.pdf
11/18/2016 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
12/06/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205433s005lbl.pdf
12/02/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf

KITABIS PAK

SOLUTION;INHALATION; 300MG/5ML
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KITABIS PAK TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 205433 PULMOFLOW INC
TOBI TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription Yes AN 050753 MYLAN SPECIALITY LP
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 201422 AKORN INC
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 205501 AMNEAL PHARMS
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 207080 DR REDDYS LABS SA
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 208964 LUPIN
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 207136 SUN PHARM
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 091589 TEVA PHARMS USA

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