Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091229
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREGABALIN | PREGABALIN | 25MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 50MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 75MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 100MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 150MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 200MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 225MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
PREGABALIN | PREGABALIN | 300MG | CAPSULE; ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
12/31/2012 | ORIG-1 | Tentative Approval |
Label is not available on this site. |