Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090453

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MOLINDONE HYDROCHLORIDE (MOLINDONE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: MOLINDONE HYDROCHLORIDE
Proprietary Name: MOLINDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090453
Product Number: 001
Approval Date: Mar 20, 2015
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MOLINDONE HYDROCHLORIDE (MOLINDONE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: MOLINDONE HYDROCHLORIDE
Proprietary Name: MOLINDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090453
Product Number: 002
Approval Date: Mar 20, 2015
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MOLINDONE HYDROCHLORIDE (MOLINDONE HYDROCHLORIDE)
25MG
Marketing Status: Prescription

Active Ingredient: MOLINDONE HYDROCHLORIDE
Proprietary Name: MOLINDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A090453
Product Number: 003
Approval Date: Mar 20, 2015
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information