Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213226
Company: MSN
Company: MSN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/13/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PREGABALIN
TABLET, EXTENDED RELEASE;ORAL; 82.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LYRICA CR | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 209501 | UPJOHN |
PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211593 | ALVOGEN |
PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214496 | EPIC PHARMA LLC |
PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213226 | MSN |
PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215249 | RUBICON |
PREGABALIN | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211889 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 165MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LYRICA CR | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 209501 | UPJOHN |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211593 | ALVOGEN |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213313 | APOTEX |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214496 | EPIC PHARMA LLC |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213226 | MSN |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215249 | RUBICON |
PREGABALIN | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211889 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 330MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LYRICA CR | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 209501 | UPJOHN |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211593 | ALVOGEN |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213313 | APOTEX |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214496 | EPIC PHARMA LLC |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213226 | MSN |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215249 | RUBICON |
PREGABALIN | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211889 | SUN PHARM |