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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050753
Company: MYLAN SPECIALITY LP

Products on NDA 050753

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBI	TOBRAMYCIN	300MG/5ML	SOLUTION;INHALATION	Prescription	AN	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050753

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1997	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050753_tobi_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050753s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050753Orig1s028ltr.pdf
12/20/2018	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050753Orig1s023Ltr.pdf
10/05/2018	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050753Orig1s022ltr.pdf
04/29/2016	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/05/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050753Orig1s018ltr.pdf
04/14/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/25/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050753Orig1s016ltr.pdf
10/24/2013	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/26/2013	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050753Orig1s011ltr.pdf
10/16/2008	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050753s009ltr.pdf
08/05/2005	SUPPL-7	Labeling		Label is not available on this site.
09/05/2001	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/18/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/21/2002	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50753s2ltr.pdf
09/11/1998	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050753

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050753s028lbl.pdf
12/20/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s023lbl.pdf
10/05/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s022lbl.pdf
10/05/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf
04/25/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf
09/26/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf

Therapeutic Equivalents for NDA 050753

TOBI

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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