Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077570
Company: HIKMA

• Other Important Information from FDA

Products on ANDA 077570

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077570

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2008	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/077570Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2019	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/16/2015	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/28/2010	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.