Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205031
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/17/2022 | 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 |
|---|---|---|---|---|---|
| 11/15/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2024 | SUPPL-5 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/15/2024 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/15/2024 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
LACOSAMIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204974 | ALEMBIC |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 214695 | ALKEM LABS LTD |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204994 | AUROBINDO PHARMA LTD |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 205006 | GLENMARK PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204787 | HETERO LABS LTD V |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 208308 | INDOCO |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 218014 | KANCHAN HLTHCARE |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 208466 | MACLEODS PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204921 | MSN LABS PVT LTD |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 205237 | SCIEGEN PHARMS INC |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 205031 | SUN PHARM |
| LACOSAMIDE | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 213109 | UNICHEM |
| VIMPAT | LACOSAMIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 022253 | UCB INC |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 204974 | ALEMBIC |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214695 | ALKEM LABS LTD |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 204994 | AUROBINDO PHARMA LTD |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 205006 | GLENMARK PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 204787 | HETERO LABS LTD V |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208308 | INDOCO |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 218014 | KANCHAN HLTHCARE |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208466 | MACLEODS PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 204921 | MSN LABS PVT LTD |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 205237 | SCIEGEN PHARMS INC |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 205031 | SUN PHARM |
| LACOSAMIDE | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213109 | UNICHEM |
| VIMPAT | LACOSAMIDE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 022253 | UCB INC |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 204974 | ALEMBIC |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 214695 | ALKEM LABS LTD |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 204994 | AUROBINDO PHARMA LTD |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 205006 | GLENMARK PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 204787 | HETERO LABS LTD V |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 208308 | INDOCO |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 218014 | KANCHAN HLTHCARE |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 208466 | MACLEODS PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 204921 | MSN LABS PVT LTD |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 205237 | SCIEGEN PHARMS INC |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 205031 | SUN PHARM |
| LACOSAMIDE | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 213109 | UNICHEM |
| VIMPAT | LACOSAMIDE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 022253 | UCB INC |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204974 | ALEMBIC |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 214695 | ALKEM LABS LTD |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204994 | AUROBINDO PHARMA LTD |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205006 | GLENMARK PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204787 | HETERO LABS LTD V |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 208308 | INDOCO |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 218014 | KANCHAN HLTHCARE |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 208466 | MACLEODS PHARMS LTD |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204921 | MSN LABS PVT LTD |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205237 | SCIEGEN PHARMS INC |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205031 | SUN PHARM |
| LACOSAMIDE | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 213109 | UNICHEM |
| VIMPAT | LACOSAMIDE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 022253 | UCB INC |