Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201463

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DRONABINOL (DRONABINOL)
2.5MG
Marketing Status: Discontinued

Active Ingredient: DRONABINOL
Proprietary Name: DRONABINOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A201463
Product Number: 001
Approval Date: May 18, 2018
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DRONABINOL (DRONABINOL)
5MG
Marketing Status: Discontinued

Active Ingredient: DRONABINOL
Proprietary Name: DRONABINOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A201463
Product Number: 002
Approval Date: May 18, 2018
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DRONABINOL (DRONABINOL)
10MG
Marketing Status: Discontinued

Active Ingredient: DRONABINOL
Proprietary Name: DRONABINOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A201463
Product Number: 003
Approval Date: May 18, 2018
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information