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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206543
Company: LUOXIN AUROVITAS

Products on ANDA 206543

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206543

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206543

IPRATROPIUM BROMIDE

SOLUTION;INHALATION; 0.02%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	206543	LUOXIN AUROVITAS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	075562	NEPHRON
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	075693	RITEDOSE CORP
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	207903	SUN PHARM

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