Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091141
Company: TEVA PHARMS USA INC

Products on ANDA 091141

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 091141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2021	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/091141Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 091141

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	216486	AUCTA
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	215621	SLAYBACK PHARMA LLC
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	091141	TEVA PHARMS USA INC
PERFOROMIST	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	Yes	AN	022007	MYLAN SPECLT