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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201820
Company: CHIESI

Summary Review

Products on NDA 201820

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETHKIS	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	AN	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201820

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
02/10/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201820s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201820Orig1s006ltr.pdf
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.

Labels for NDA 201820

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201820s006lbl.pdf
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

Therapeutic Equivalents for NDA 201820

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	216725	MANKIND PHARMA
TOBRAMYCIN	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	No	AN	210915	TEVA PHARMS USA

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