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Details for New Drug Application (NDA): 022445
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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: | 7 |
Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022445
Generic Entry Date for 022445*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTION, EXTENDED RELEASE;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 022445
Mechanism of Action | Serotonin 3 Receptor Antagonists |
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: | RX | Dosage: | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 10MG/0.4ML (10MG/0.4ML) | ||||
Approval Date: | Aug 9, 2016 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | 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: | Start Trial | Patent Expiration: | Jun 28, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | May 11, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? |
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