Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216426
Company: LEXENPHARM

Products on ANDA 216426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216426

FORMOTEROL FUMARATE

SOLUTION;INHALATION; 0.02MG/2ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215078	ALEMBIC
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	218308	DEVA HOLDING AS
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215907	DR REDDYS
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	216426	LEXENPHARM
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215053	LUPIN
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215883	MANKIND PHARMA
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	218304	MICRO LABS
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	216486	RITEDOSE CORP
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	091141	TEVA PHARMS USA INC
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215621	WILSHIRE PHARMS INC
PERFOROMIST	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	Yes	AN	022007	VIATRIS SPECIALTY