Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211199
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | AB | No | No |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | AB | No | No |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 800MG | 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 |
---|---|---|---|---|---|---|---|
10/06/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ESLICARBAZEPINE ACETATE
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APTIOM | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 022416 | SUMITOMO PHARMA AM |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | No | AB | 211199 | ALKEM LABS LTD |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | No | AB | 211238 | DR REDDYS |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | No | AB | 211186 | HETERO LABS LTD V |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | No | AB | 211246 | LUPIN LTD |
TABLET;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APTIOM | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | Yes | AB | 022416 | SUMITOMO PHARMA AM |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | No | AB | 211199 | ALKEM LABS LTD |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | No | AB | 211238 | DR REDDYS |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | No | AB | 211186 | HETERO LABS LTD V |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | No | AB | 211246 | LUPIN LTD |
TABLET;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APTIOM | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | Yes | AB | 022416 | SUMITOMO PHARMA AM |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | No | AB | 211199 | ALKEM LABS LTD |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | No | AB | 211238 | DR REDDYS |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | No | AB | 211186 | HETERO LABS LTD V |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | No | AB | 211246 | LUPIN LTD |
TABLET;ORAL; 800MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APTIOM | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Prescription | Yes | AB | 022416 | SUMITOMO PHARMA AM |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Prescription | No | AB | 211199 | ALKEM LABS LTD |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Prescription | No | AB | 211238 | DR REDDYS |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Prescription | No | AB | 211186 | HETERO LABS LTD V |
ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Prescription | No | AB | 211246 | LUPIN LTD |