Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091219
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | AB | No | No |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/19/2019 | ORIG-1 | Approval |
Label is not available on this site. |
PREGABALIN
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091219 | TEVA PHARMS |
CAPSULE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | UPJOHN |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | ACI |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091025 | ACTAVIS ELIZABETH |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211685 | APOTEX |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 212280 | CIPLA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | RENATA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209883 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091219 | TEVA PHARMS |