Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 091224
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | AB | No | No |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | AB | No | No |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | AB | No | No |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | AB | No | No |
| PREGABALIN | PREGABALIN | 300MG | 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; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | PF PRISM CV |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC PHARMS LTD |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210891 | HAINAN |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN LABS PVT LTD |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 091228 | MYLAN |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | PF PRISM CV |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC PHARMS LTD |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN LABS PVT LTD |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 091228 | MYLAN |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | PF PRISM CV |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC PHARMS LTD |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN LABS PVT LTD |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 091228 | MYLAN |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | PF PRISM CV |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC PHARMS LTD |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN LABS PVT LTD |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 091228 | MYLAN |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 225MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | PF PRISM CV |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC PHARMS LTD |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN LABS PVT LTD |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 091228 | MYLAN |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
CAPSULE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 021446 | PF PRISM CV |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC PHARMS LTD |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 207799 | ALKEM LABS LTD |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209743 | AMNEAL PHARMS CO |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210891 | HAINAN |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 206912 | HETERO LABS LTD III |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211384 | INVAGEN PHARMS |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN LABS PVT LTD |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 091228 | MYLAN |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS INC |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 091224 | TEVA PHARMS |
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