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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203433
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription AB No No
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription AB No No
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 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
12/17/2020 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2023 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
02/08/2023 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
09/20/2021 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/203433Orig1s002.pdf

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

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
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 203433 HIKMA
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 213948 TEVA PHARMS USA
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 208891 MYLAN

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
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 203433 HIKMA
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 213948 TEVA PHARMS USA
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 208891 MYLAN

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
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 203433 HIKMA
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 213948 TEVA PHARMS USA
WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription No AB 208891 MYLAN
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