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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214464
Company: RESPIRENT PHARMS

Products on ANDA 214464

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214464

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	214464	RESPIRENT PHARMS
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	214464	RESPIRENT PHARMS
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

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