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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215385
Company: SUN PHARM

Products on ANDA 215385

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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

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Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215385

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
05/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

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Supplements

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Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
12/21/2022	SUPPL-1	Labeling-Patient Package Insert		Label is not available on this site.

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Therapeutic Equivalents for ANDA 215385

ARFORMOTEROL TARTRATE

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

CSV Excel Print

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	214901	AIPING PHARM INC
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	218380	AUCTA
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	213762	BE PHARMS
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	216303	CF PHARMTECH
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	215032	DR REDDYS
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	218156	LEXENPHARM
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	218555	MICRO LABS
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	215385	SUN PHARM
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	200293	TEVA PHARMS USA
ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	No	AN	216815	WILSHIRE PHARMS INC
BROVANA	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription	Yes	AN	021912	LUPIN

Showing 1 to 16 of 16 entries

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