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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213762
Company: SLATE RUN PHARMA
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
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 STANDARD

Label is not available on this site.

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 PHARMS LTD
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 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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