Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075948
Company: APOTEX INC

• Healthcare Professional Sheet

Products on ANDA 075948

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075948

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2002	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
11/08/2022	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/20/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/04/2011	SUPPL-7	REMS-Proposal		Label is not available on this site.
11/25/2009	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/28/2008	SUPPL-3	Labeling		Label is not available on this site.
10/15/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075948

CARBAMAZEPINE

TABLET;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;ORAL	Prescription	No	AB	075948	APOTEX INC
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	No	AB	218221	BIONPHARMA
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	No	AB	074649	TARO
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	No	AB	077272	TORRENT PHARMS
CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	No	AB	213284	UNICHEM
EPITOL	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	No	AB	070541	TEVA
TEGRETOL	CARBAMAZEPINE	200MG	TABLET;ORAL	Prescription	Yes	AB	016608	NOVARTIS