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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021397
Company: PARKE DAVIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEURONTIN GABAPENTIN 600MG TABLET; ORAL Prescription 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
05/24/2002 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397_21-423_21-424_Neurontin.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/24/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Prntlbl.pdf
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