Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213311
Company: CSPC OUYI
Company: CSPC OUYI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
04/13/2021 | 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 |
---|---|---|---|---|---|
01/09/2024 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
CARBAMAZEPINE
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216404 | RICONPHARMA LLC |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216235 | SCIECURE PHARMA INC |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216594 | UMEDICA |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215591 | ZHEJIANG JIUZHOU |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
TEGRETOL-XR | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216404 | RICONPHARMA LLC |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216235 | SCIECURE PHARMA INC |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216594 | UMEDICA |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215591 | ZHEJIANG JIUZHOU |
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
TEGRETOL-XR | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216404 | RICONPHARMA LLC |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216235 | SCIECURE PHARMA INC |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216594 | UMEDICA |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215591 | ZHEJIANG JIUZHOU |
CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
TEGRETOL-XR | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |