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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215053
Company: LUPIN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/22/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

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 PHARMS LTD
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 091141 TEVA PHARMS USA INC
PERFOROMIST FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION;INHALATION Prescription Yes AN 022007 MYLAN SPECLT
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