Details for New Drug Application (NDA): 078292
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NDA 078292 describes DRONABINOL, which is a drug marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, and Svc Pharma, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DRONABINOL profile page.
The generic ingredient in DRONABINOL 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.
The generic ingredient in DRONABINOL 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 078292
| Tradename: | DRONABINOL |
| Applicant: | Svc Pharma |
| Ingredient: | dronabinol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078292
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRONABINOL | dronabinol | CAPSULE;ORAL | 078292 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-867 | 42858-867-06 | 60 CAPSULE in 1 BOTTLE (42858-867-06) |
| DRONABINOL | dronabinol | CAPSULE;ORAL | 078292 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-868 | 42858-868-06 | 60 CAPSULE in 1 BOTTLE (42858-868-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jun 27, 2008 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 27, 2008 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 27, 2008 | TE: | RLD: | No | |||||
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