Details for New Drug Application (NDA): 018651
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The generic ingredient in MARINOL 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 018651
Tradename: | MARINOL |
Applicant: | Alkem Labs Ltd |
Ingredient: | dronabinol |
Patents: | 0 |
Suppliers and Packaging for NDA: 018651
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MARINOL | dronabinol | CAPSULE;ORAL | 018651 | NDA AUTHORIZED GENERIC | Major Pharmaceuticals | 0904-7144 | 0904-7144-61 | 100 BLISTER PACK in 1 CARTON (0904-7144-61) / 1 CAPSULE in 1 BLISTER PACK |
MARINOL | dronabinol | CAPSULE;ORAL | 018651 | NDA AUTHORIZED GENERIC | Major Pharmaceuticals | 0904-7145 | 0904-7145-04 | 30 BLISTER PACK in 1 CARTON (0904-7145-04) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
Approval Date: | May 31, 1985 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | May 31, 1985 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | May 31, 1985 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 018651
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-001 | May 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-003 | May 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-002 | May 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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