Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021216
Company: PARKE DAVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEURONTIN GABAPENTIN 250MG/5ML SOLUTION; 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
10/12/2000 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/12/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf

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