An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212948
Company: ANBISON LAB

Products on ANDA 212948

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212948

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212948

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	219939	ALEMBIC
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217277	ALKEM LABS LTD
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	NOVAST LABS
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	212524	TORRENT
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	219072	YICHANG HUMANWELL
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	219939	ALEMBIC
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217277	ALKEM LABS LTD
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	NOVAST LABS
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	212524	TORRENT
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	219072	YICHANG HUMANWELL
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	219939	ALEMBIC
CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217277	ALKEM LABS LTD
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	NOVAST LABS
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	212524	TORRENT
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	219072	YICHANG HUMANWELL
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

Top