Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211149
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 39MG/0.25ML (39MG/0.25ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription AB No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 78MG/0.5ML (78MG/0.5ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription AB No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 117MG/0.75ML (117MG/0.75ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription AB No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 156MG/ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription AB No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 234MG/1.5ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/06/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211149Orig1s000ltr.pdf

PALIPERIDONE PALMITATE

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 39MG/0.25ML (39MG/0.25ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA SUSTENNA PALIPERIDONE PALMITATE 39MG/0.25ML (39MG/0.25ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription Yes AB 022264 JANSSEN PHARMS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 39MG/0.25ML (39MG/0.25ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription No AB 211149 TEVA PHARMS USA

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 78MG/0.5ML (78MG/0.5ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA SUSTENNA PALIPERIDONE PALMITATE 78MG/0.5ML (78MG/0.5ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription Yes AB 022264 JANSSEN PHARMS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 78MG/0.5ML (78MG/0.5ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription No AB 211149 TEVA PHARMS USA

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 117MG/0.75ML (117MG/0.75ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA SUSTENNA PALIPERIDONE PALMITATE 117MG/0.75ML (117MG/0.75ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription Yes AB 022264 JANSSEN PHARMS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 117MG/0.75ML (117MG/0.75ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription No AB 211149 TEVA PHARMS USA

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 156MG/ML (156MG/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA SUSTENNA PALIPERIDONE PALMITATE 156MG/ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription Yes AB 022264 JANSSEN PHARMS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 156MG/ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription No AB 211149 TEVA PHARMS USA

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 234MG/1.5ML (156MG/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA SUSTENNA PALIPERIDONE PALMITATE 234MG/1.5ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription Yes AB 022264 JANSSEN PHARMS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 234MG/1.5ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription No AB 211149 TEVA PHARMS USA

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