Details for New Drug Application (NDA): 201463
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NDA 201463 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 201463
| Tradename: | DRONABINOL |
| Applicant: | Lannett Co Inc |
| Ingredient: | dronabinol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201463
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRONABINOL | dronabinol | CAPSULE;ORAL | 201463 | ANDA | Lannett Company, Inc. | 0527-1450 | 0527-1450-06 | 60 CAPSULE in 1 BOTTLE, PLASTIC (0527-1450-06) |
| DRONABINOL | dronabinol | CAPSULE;ORAL | 201463 | ANDA | Lannett Company, Inc. | 0527-1451 | 0527-1451-06 | 60 CAPSULE in 1 BOTTLE, PLASTIC (0527-1451-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | May 18, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 18, 2018 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 18, 2018 | TE: | RLD: | No | |||||
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