Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208891
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription AB No No
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription AB No No
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription AB 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
01/30/2019 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208891Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208891Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/30/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208891Orig1s000lbl.pdf

WIXELA INHUB

POWDER;INHALATION; 0.1MG/INH;EQ 0.05MG BASE/INH
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADVAIR DISKUS 100/50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription Yes AB 021077 GLAXO GRP LTD
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 208891 MYLAN PHARMS INC

POWDER;INHALATION; 0.25MG/INH;EQ 0.05MG BASE/INH
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADVAIR DISKUS 250/50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription Yes AB 021077 GLAXO GRP LTD
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 208891 MYLAN PHARMS INC

POWDER;INHALATION; 0.5MG/INH;EQ 0.05MG BASE/INH
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADVAIR DISKUS 500/50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription Yes AB 021077 GLAXO GRP LTD
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 208891 MYLAN PHARMS INC

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