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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205433
Company: PULMOFLOW INC

Products on NDA 205433

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205433

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/2014/205433Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.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
04/10/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205433Orig1s008ltr.pdf
02/10/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205433Orig1s007ltr.pdf
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.

Labels for NDA 205433

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s008lbl.pdf
02/10/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s007lbl.pdf
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

Therapeutic Equivalents for NDA 205433

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	212848	ALKEM LABS LTD
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	201422	HIKMA
TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION;INHALATION	Prescription	No	AN	208964	LUPIN
TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION;INHALATION	Prescription	No	AN	214478	MANKIND PHARMA
TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION;INHALATION	Prescription	No	AN	217344	MICRO LABS
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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