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Details for New Drug Application (NDA): 205525
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NDA 205525 describes SYNDROS, which is a drug marketed by Benuvia and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SYNDROS profile page.
The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
Summary for 205525
| Tradename: | SYNDROS |
| Applicant: | Benuvia |
| Ingredient: | dronabinol |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205525
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYNDROS | dronabinol | SOLUTION;ORAL | 205525 | NDA | Insys Therapeutics, Inc. | 20482-335 | 20482-335-30 | 1 BOTTLE, GLASS in 1 CARTON (20482-335-30) > 30 mL in 1 BOTTLE, GLASS |
Paragraph IV (Patent) Challenges for 205525
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SYNDROS | SOLUTION;ORAL | dronabinol | 205525 | 2017-04-17 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/ML | ||||
| Approval Date: | Mar 23, 2017 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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