Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075714
Company: CHARTWELL RX

• Healthcare Professional Sheet

Products on ANDA 075714

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2002	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-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/26/2012	SUPPL-7	Labeling-Medication Guide, REMS-Proposal		Label is not available on this site.
12/15/2009	SUPPL-5	Labeling		Label is not available on this site.
03/14/2008	SUPPL-4	Labeling		Label is not available on this site.
01/11/2008	SUPPL-3	Labeling		Label is not available on this site.
04/09/2004	SUPPL-2	Labeling		Label is not available on this site.
11/05/2003	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075714

CARBAMAZEPINE

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