Details for New Drug Application (NDA): 207421
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NDA 207421 describes DRONABINOL, which is a drug marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, and Rhodes, and is included in five NDAs. It is available from one supplier. Additional details are available on the DRONABINOL profile page.
The generic ingredient in DRONABINOL is dronabinol. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
The generic ingredient in DRONABINOL is dronabinol. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
Summary for 207421
| Tradename: | DRONABINOL |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | dronabinol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207421
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRONABINOL | dronabinol | CAPSULE;ORAL | 207421 | ANDA | Camber Pharmaceuticals Inc | 31722-960 | 31722-960-60 | 60 CAPSULE in 1 BOTTLE (31722-960-60) |
| DRONABINOL | dronabinol | CAPSULE;ORAL | 207421 | ANDA | Camber Pharmaceuticals Inc | 31722-961 | 31722-961-60 | 60 CAPSULE in 1 BOTTLE (31722-961-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Feb 7, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 7, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 7, 2020 | TE: | AB | RLD: | No | ||||
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