Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076504
Company: HIKMA

Products on ANDA 076504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2006	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76504ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076504_original approval_package.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/10/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/21/2008	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076504

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL; 0.05MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	077538	APOTEX INC
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	078492	CHARTWELL RX
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076504	HIKMA