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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078986
Company: APOTEX INC

Products on ANDA 078986

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078986

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2011	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
08/08/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/08/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/08/2022	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/08/2022	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/18/2014	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078986

CARBAMAZEPINE

CAPSULE, 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	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078986	APOTEX INC
CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	076697	NOSTRUM LABS INC
CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	201106	TARO
CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078592	TEVA PHARMS
CARBATROL	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020712	TAKEDA PHARMS USA

CAPSULE, 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	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078986	APOTEX INC
CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	076697	NOSTRUM LABS INC
CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	201106	TARO
CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078592	TEVA PHARMS
CARBATROL	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020712	TAKEDA PHARMS USA

CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078986	APOTEX INC
CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	076697	NOSTRUM LABS INC
CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	201106	TARO
CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078592	TEVA PHARMS
CARBATROL	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020712	TAKEDA PHARMS USA

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