Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074805
Company: BAUSCH

Products on ANDA 074805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUNISOLIDE	FLUNISOLIDE	0.025MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74805ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2024	SUPPL-22	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/18/2004	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074805

FLUNISOLIDE

SPRAY, METERED;NASAL; 0.025MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUNISOLIDE	FLUNISOLIDE	0.025MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	074805	BAUSCH
FLUNISOLIDE	FLUNISOLIDE	0.025MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	207802	RICONPHARMA LLC
FLUNISOLIDE	FLUNISOLIDE	0.025MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	077704	RISING