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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076729
Company: TARO

Products on ANDA 076729

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERIL	CARBAMAZEPINE	100MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076729

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2004	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
02/28/2020	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/08/2016	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/13/2013	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/24/2012	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal		Label is not available on this site.
01/27/2010	SUPPL-4	Labeling		Label is not available on this site.
04/17/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076729

TERIL

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAMAZEPINE	CARBAMAZEPINE	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	075714	CHARTWELL RX
CARBAMAZEPINE	CARBAMAZEPINE	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	214277	NOVITIUM PHARMA
TEGRETOL	CARBAMAZEPINE	100MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	018927	NOVARTIS
TERIL	CARBAMAZEPINE	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	076729	TARO

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