Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203760
Company: PADAGIS US

Products on ANDA 203760

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203760

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2020	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203760Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/203760Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203760

ALBUTEROL SULFATE

AEROSOL, METERED;INHALATION; EQ 0.09MG BASE/INH
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	211600	AMNEAL IRELAND LTD
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	212447	ARMSTRONG PHARMS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	209954	LUPIN
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	203760	PADAGIS US
PROAIR HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB2	021457	TEVA BRANDED PHARM