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Details for New Drug Application (NDA): 022445
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.
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
| 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 | |||||
| Regulatory Exclusivity Expiration: | Aug 9, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW DOSAGE FORM | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 28, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | May 11, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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