Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212865
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | AB | No | No |
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/20/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2024 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/23/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
PREGABALIN
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 | 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 | 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 | 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 | 209530 | JUBILANT GENERICS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091222 | PHARMOBEDIENT |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 208113 | REGCON HOLDINGS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | SOMERSET THERAPS LLC |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 206942 | TORRENT |
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 | UPJOHN |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| 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 | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| 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 | 209530 | JUBILANT GENERICS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 091222 | PHARMOBEDIENT |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 208113 | REGCON HOLDINGS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | SOMERSET THERAPS LLC |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 206942 | TORRENT |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210891 | YILING |
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 | UPJOHN |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| 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 | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| 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 | 209530 | JUBILANT GENERICS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 091222 | PHARMOBEDIENT |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208113 | REGCON HOLDINGS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | SOMERSET THERAPS LLC |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206942 | TORRENT |
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 | UPJOHN |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 216197 | ADAPTIS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 203459 | ALEMBIC |
| 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 | 205321 | AUROBINDO PHARMA |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 214322 | CHANGZHOU PHARM |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 212865 | CHARTWELL RX |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 213423 | CREEKWOOD PHARMS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209664 | DR REDDYS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 212988 | ESKAYEF |
| 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 | 209530 | JUBILANT GENERICS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 209357 | MSN |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 091222 | PHARMOBEDIENT |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 207883 | PRINSTON INC |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 208113 | REGCON HOLDINGS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 210432 | RISING |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 208677 | SCIEGEN PHARMS |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 210585 | SOMERSET THERAPS LLC |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 215755 | STRIDES PHARMA |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 206942 | TORRENT |