Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 018651

Expand all

MARINOL (DRONABINOL)
2.5MG
Marketing Status: Prescription

Active Ingredient: DRONABINOL
Proprietary Name: MARINOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018651
Product Number: 001
Approval Date: May 31, 1985
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MARINOL (DRONABINOL)
5MG
Marketing Status: Prescription

Active Ingredient: DRONABINOL
Proprietary Name: MARINOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018651
Product Number: 002
Approval Date: May 31, 1985
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MARINOL (DRONABINOL)
10MG
Marketing Status: Prescription

Active Ingredient: DRONABINOL
Proprietary Name: MARINOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018651
Product Number: 003
Approval Date: May 31, 1985
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information