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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 Discontinued None No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 78MG/0.5ML (78MG/0.5ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 117MG/0.75ML (117MG/0.75ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 156MG/ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 234MG/1.5ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None 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)

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