Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207306
Company: CIPLA
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207306Orig1s000ltr.pdf

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 213762 AXAR PHARMS INC
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 213132 GLENMARK PHARMS LTD
BROVANA ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION;INHALATION Prescription Yes AN 021912 SUNOVION

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