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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201688
Company: MYLAN SPECIALITY LP

Summary Review

Products on NDA 201688

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBI PODHALER	TOBRAMYCIN	28MG	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201688

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201688s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201688Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201688s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201688Orig1s019ltr.pdf
07/13/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201688s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201688Orig1s010ltr.pdf
01/27/2017	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201688s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201688Orig1s008ltr.pdf
01/06/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/02/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201688Orig1s006ltr.pdf
09/11/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/19/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s004ltr.pdf
09/30/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/25/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s002ltr.pdf
01/07/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201688

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201688s019lbl.pdf
07/13/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201688s010lbl.pdf
12/16/2016	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201688s008lbl.pdf
10/02/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf
11/19/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s004lbl.pdf
04/25/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf
03/22/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201688s000lbl.pdf

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