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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020949
Company: MYLAN SPECIALITY LP

Patient Information Sheet

Products on NDA 020949

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACCUNEB	ALBUTEROL SULFATE	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INHALATION	Discontinued	None	Yes	No
ACCUNEB	ALBUTEROL SULFATE	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INHALATION	Discontinued	None	Yes	No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 020949

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2001	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-949_AccuNeb.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2022	SUPPL-27	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020949Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020949Orig1s027ltr.pdf
09/30/2013	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
09/30/2013	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/02/2011	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020949s024ltr.pdf
06/02/2006	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf
11/13/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/20/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/20/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020949

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2022	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020949Orig1s027lbl.pdf
04/28/2022	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020949Orig1s027lbl.pdf
03/02/2011	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf

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