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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207533

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ARISTADA (ARIPIPRAZOLE LAUROXIL)
441MG/1.6ML (275.63MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE LAUROXIL
Proprietary Name: ARISTADA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 441MG/1.6ML (275.63MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207533
Product Number: 001
Approval Date: Oct 5, 2015
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARISTADA (ARIPIPRAZOLE LAUROXIL)
662MG/2.4ML (275.83MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE LAUROXIL
Proprietary Name: ARISTADA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 662MG/2.4ML (275.83MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207533
Product Number: 002
Approval Date: Oct 5, 2015
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARISTADA (ARIPIPRAZOLE LAUROXIL)
882MG/3.2ML (275.63MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE LAUROXIL
Proprietary Name: ARISTADA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 882MG/3.2ML (275.63MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207533
Product Number: 003
Approval Date: Oct 5, 2015
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARISTADA (ARIPIPRAZOLE LAUROXIL)
1064MG/3.9ML (272.82MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE LAUROXIL
Proprietary Name: ARISTADA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 1064MG/3.9ML (272.82MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207533
Product Number: 004
Approval Date: Jun 5, 2017
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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