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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 203433

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 203433

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
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

Therapeutic Equivalents for ANDA 203433

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

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