Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021724
Company: CP PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYRICA PREGABALIN 25MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 50MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 75MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 100MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 150MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 200MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 225MG CAPSULE; ORAL Prescription None No No
LYRICA PREGABALIN 300MG CAPSULE; 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
06/10/2005 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021724ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021724s000TOC.cfm

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