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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200293
Company: TEVA PHARMS USA

Products on ANDA 200293

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200293

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2021	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 200293

ARFORMOTEROL TARTRATE

SOLUTION;INHALATION; EQ 0.015MG BASE/2ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	214779	ALEMBIC
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	207306	CIPLA
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	213068	LUPIN
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	216128	MANKIND PHARMA
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	214901	PHARMAMAX
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	214736	RITEDOSE CORP
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	213762	SLATE RUN PHARMA
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	216815	SLAYBACK PHARMA LLC
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	215385	SUN PHARM
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	200293	TEVA PHARMS USA
BROVANA	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	Yes	AN	021912	LUPIN

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