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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020950
Company: MYLAN SPECIALITY LP

Patient Information Sheet

Products on NDA 020950

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUONEB	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020950

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2001	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2013	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
05/29/2012	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020950s037ltr.pdf
03/03/2011	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020950s032ltr.pdf
09/26/2005	SUPPL-18	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020950s018ltr.pdf
06/02/2006	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020950s012LTR.pdf
12/10/2002	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/28/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/12/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/20/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/20/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/31/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/18/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020950

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2012	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf
03/03/2011	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf
03/21/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf

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