Details for New Drug Application (NDA): 205525
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The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
Summary for 205525
Tradename: | SYNDROS |
Applicant: | Benuvia Operations |
Ingredient: | dronabinol |
Patents: | 4 |
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 | Benuvia Operations, LLC | 78613-201 | 78613-201-30 | 1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 5MG/ML | ||||
Approval Date: | Mar 23, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 6, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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