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Generated: November 18, 2018

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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 six 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:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 022445
Medical Subject Heading (MeSH) Categories for 022445
Suppliers and Packaging for NDA: 022445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445 NDA Heron Therapeutics 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:RXDosage:INJECTION, EXTENDED RELEASE;SUBCUTANEOUSStrength10MG/0.4ML (10MG/0.4ML)
Approval Date:Aug 9, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 9, 2019
Regulatory Exclusivity Use:NEW DOSAGE FORM
Patent:➤ Sign UpPatent Expiration:Jun 28, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 11, 2021Product Flag?YSubstance Flag?Delist Request?

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