Details for New Drug Application (NDA): 022048

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NDA 022048 describes TRIESENCE, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the TRIESENCE profile page.

The generic ingredient in TRIESENCE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for 022048

Tradename:	TRIESENCE
Applicant:	Harrow Eye
Ingredient:	triamcinolone acetonide
Patents:	2

Pharmacology for NDA: 022048

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 022048

Anti-Inflammatory Agents
Glucocorticoids
Immunosuppressive Agents

Suppliers and Packaging for NDA: 022048

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048	NDA	Novartis Pharmaceuticals Corporation	0078-0897	0078-0897-78	1 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS
TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048	NDA	Harrow Eye, LLC	82667-800	82667-800-01	1 BLISTER PACK in 1 CARTON (82667-800-01) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVITREAL			Strength	40MG/ML (40MG/ML)
Approval Date:	Nov 29, 2007	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 17, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 10, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPHTHALMIC DISORDERS
Patent:	⤷ Sign Up	Patent Expiration:	Mar 10, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	VISUALIZATION DURING VITRECTOMY PROCEDURES

Expired US Patents for NDA 022048

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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