Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021724
Company: CP PHARMS
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 |