Details for New Drug Application (NDA): 022445
✉ Email this page to a colleague
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.
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
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: | ⤷ Subscribe | 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: | ⤷ Subscribe | Patent Expiration: | Sep 28, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
