Details for New Drug Application (NDA): 207421
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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 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 | Lannett Company, Inc. | 0527-4125 | 0527-4125-35 | 60 CAPSULE in 1 BOTTLE (0527-4125-35) |
DRONABINOL | dronabinol | CAPSULE;ORAL | 207421 | ANDA | Camber Pharmaceuticals Inc | 31722-960 | 31722-960-60 | 60 CAPSULE in 1 BOTTLE (31722-960-60) |
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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