Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212604
Company: PATRIN
Company: PATRIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREGABALIN | PREGABALIN | 20MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
02/18/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PREGABALIN
SOLUTION;ORAL; 20MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LYRICA | PREGABALIN | 20MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 022488 | UPJOHN |
PREGABALIN | PREGABALIN | 20MG/ML | SOLUTION;ORAL | Prescription | No | AA | 207623 | ALKEM LABS LTD |
PREGABALIN | PREGABALIN | 20MG/ML | SOLUTION;ORAL | Prescription | No | AA | 212604 | PATRIN |