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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 seven 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.
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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