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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205636
Company: TEVA BRANDED PHARM

Summary Review

Products on NDA 205636

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROAIR DIGIHALER	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	POWDER, METERED;INHALATION	Prescription	None	Yes	No
PROAIR RESPICLICK	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	POWDER, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205636

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)	Label for PROAIR RESPICLICK	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205636s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2023	SUPPL-28	Labeling-Container/Carton Labels		Label is not available on this site.
01/27/2022	SUPPL-23	Labeling-Container/Carton Labels		Label is not available on this site.
09/29/2020	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205636s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205636Orig1s020ltr.pdf
01/09/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)	Letter and Label for PROAIR DIGIHALER	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205636Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205636Orig1s012ltr.pdf
09/08/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)	Letter and Label for PROAIR RESPICLICK	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s006ltr.pdf
05/11/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/28/2016	SUPPL-4	Efficacy-New Patient Population	Label (PDF) Letter (PDF)	Letter and Label for PROAIR RESPICLICK	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s004ltr.pdf
12/11/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/30/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/30/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205636

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205636s020lbl.pdf
09/29/2020	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205636s020lbl.pdf
01/09/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)	Letter and Label for PROAIR DIGIHALER	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205636Orig1s012lbl.pdf
09/08/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)	Letter and Label for PROAIR RESPICLICK	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s006lbl.pdf
04/28/2016	SUPPL-4	Efficacy-New Patient Population	Label (PDF)	Letter and Label for PROAIR RESPICLICK	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s004lbl.pdf
03/31/2015	ORIG-1	Approval	Label (PDF)	Label for PROAIR RESPICLICK	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205636s000lbl.pdf

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