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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208294
Company: ASTRAZENECA

Products on NDA 208294

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEVESPI AEROSPHERE	FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2016	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208294s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208294Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208294Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208294s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208294Orig1s009ltr.pdf
05/29/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208294s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208294Orig1s005ltr.pdf

Labels for NDA 208294

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208294s009lbl.pdf
05/29/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208294s005lbl.pdf
05/29/2019	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208294s005lbl.pdf
04/25/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208294s000lbl.pdf

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