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Details for New Drug Application (NDA): 207533

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NDA 207533 describes ARISTADA, which is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ARISTADA profile page.

The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.

Summary for NDA: 207533

Tradename:
ARISTADA
Applicant:
Alkermes Inc
Ingredient:
aripiprazole lauroxil
Patents:5

Suppliers and Packaging for NDA: 207533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533 NDA Alkermes, Inc. 65757-401 65757-401-03 1 SYRINGE in 1 CARTON (65757-401-03) > 1.6 mL in 1 SYRINGE (65757-401-01)
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533 NDA Alkermes, Inc. 65757-402 65757-402-03 1 SYRINGE in 1 CARTON (65757-402-03) > 2.4 mL in 1 SYRINGE (65757-402-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength441MG/1.6ML (275.63MG/ML)
Approval Date:Oct 5, 2015TE:RLD:No
Patent:8,431,576Patent Expiration:Oct 26, 2030Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Oct 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:8,796,276Patent Expiration:Jun 24, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA


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