Details for New Drug Application (NDA): 022445

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NDA 022445 describes SUSTOL, which is a drug marketed by Heron Theraps Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the SUSTOL profile page.

The generic ingredient in SUSTOL is granisetron. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the granisetron profile page.

Summary for 022445

Tradename:	SUSTOL
Applicant:	Heron Theraps Inc
Ingredient:	granisetron
Patents:	5

Pharmacology for NDA: 022445

Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 022445

Antiemetics
Serotonin Antagonists

Suppliers and Packaging for NDA: 022445

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445	NDA	Heron Therapeutics, Inc.	47426-101	47426-101-06	6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	10MG/0.4ML (10MG/0.4ML)
Approval Date:	Aug 9, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 28, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PROPHYLACTIC TREATMENT OF NAUSEA AND VOMITING, INCLUDING PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED CHEMOTHERAPY
Patent:	⤷ Sign Up	Patent Expiration:	Sep 28, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 28, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OR PREVENTION OF NAUSEA AND VOMITING

Expired US Patents for NDA 022445

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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