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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215591
Company: ZHEJIANG JIUZHOU
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
03/31/2022 ORIG-1 Approval STANDARD

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 078115 TARO
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 216594 UMEDICA LABS PVT LTD
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 078115 TARO
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 216594 UMEDICA LABS PVT LTD
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 078115 TARO
CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 216594 UMEDICA LABS PVT LTD
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
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