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Details for New Drug Application (NDA): 205525
NDA 205525 describes SYNDROS, which is a drug marketed by Insys Dev Co Inc and is included in one NDA. It is available from one supplier. There are two 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
Summary for 205525
| Tradename: | SYNDROS |
| Applicant: | Insys Dev Co Inc |
| Ingredient: | dronabinol |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205525
| Ingredient-type | Cannabinoids |
Medical Subject Heading (MeSH) Categories for 205525
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 |
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: | ➤ Try a Free Trial | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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