Details for New Drug Application (NDA): 022198
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NDA 022198 describes SANCUSO, which is a drug marketed by Cumberland and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SANCUSO profile page.
The generic ingredient in SANCUSO 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 SANCUSO 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 022198
| Tradename: | SANCUSO |
| Applicant: | Cumberland |
| Ingredient: | granisetron |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022198
Generic Entry Date for 022198*:
Constraining patent/regulatory exclusivity:
Dosage:
FILM, EXTENDED RELEASE;TRANSDERMAL |
*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: 022198
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 022198
Suppliers and Packaging for NDA: 022198
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SANCUSO | granisetron | FILM, EXTENDED RELEASE;TRANSDERMAL | 022198 | NDA | Cumberland Pharmaceuticals Inc. | 66220-637 | 66220-637-31 | 168 h in 1 POUCH (66220-637-31) |
| SANCUSO | granisetron | FILM, EXTENDED RELEASE;TRANSDERMAL | 022198 | NDA | Cumberland Pharmaceuticals Inc. | 66220-637 | 66220-637-72 | 168 h in 1 POUCH (66220-637-72) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 3.1MG/24HR | ||||
| Approval Date: | Sep 12, 2008 | TE: | RLD: | Yes | |||||
| Patent: | 7,608,282 | Patent Expiration: | Jan 22, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING | ||||||||
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