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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021929
Company: ASTRAZENECA

Other Important Information from FDA

Products on NDA 021929

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	Yes	Yes
SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021929

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2006	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021929lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021929ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021929_symbicort_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2017	SUPPL-42	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s042ltr.pdf
09/11/2017	SUPPL-41	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s041ltr.pdf
06/10/2016	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
06/28/2014	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
04/14/2015	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
04/04/2014	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
02/27/2014	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
01/15/2014	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
07/23/2012	SUPPL-33	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021929Orig1s033ltr.pdf
05/08/2012	SUPPL-30	Labeling-Medication Guide		Label is not available on this site.
08/18/2011	SUPPL-28	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021929s028ltr.pdf
06/25/2010	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021929s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021929s021ltr.pdf
02/16/2011	SUPPL-19	REMS-Modified, REMS-Assessment	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021929s019ltr.pdf
01/27/2017	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s013ltr.pdf
02/27/2009	SUPPL-12	Efficacy-New Indication, REMS-Proposal	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021929s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021929Orig1s012.pdf
07/16/2008	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021929s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021929s010ltr.pdf
10/26/2007	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021929s006ltr.pdf
10/31/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021929s004ltr.pdf

Labels for NDA 021929

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2017	SUPPL-42	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s042lbl.pdf
09/11/2017	SUPPL-41	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf
01/27/2017	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf
06/25/2010	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021929s021lbl.pdf
02/27/2009	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf
02/27/2009	SUPPL-12	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf
07/16/2008	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021929s010lbl.pdf
10/31/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s004lbl.pdf
10/26/2007	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s006lbl.pdf
07/21/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021929lbl.pdf

Therapeutic Equivalents for NDA 021929

SYMBICORT

AEROSOL, METERED;INHALATION; 0.08MG/INH;0.0045MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREYNA	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	211699	MYLAN
SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB	021929	ASTRAZENECA

AEROSOL, METERED;INHALATION; 0.16MG/INH;0.0045MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREYNA	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	211699	MYLAN
SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB	021929	ASTRAZENECA

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