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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072879
Company: CHARTWELL RX

Products on ANDA 072879

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXAPINE	AMOXAPINE	150MG	TABLET;ORAL	Prescription	AB	No	No
AMOXAPINE	AMOXAPINE	25MG	TABLET;ORAL	Prescription	AB	No	No
AMOXAPINE	AMOXAPINE	50MG	TABLET;ORAL	Prescription	AB	No	No
AMOXAPINE	AMOXAPINE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072879

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/1991	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
05/29/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/17/2014	SUPPL-14	Labeling-Patient Package Insert		Label is not available on this site.
03/25/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
05/22/2001	SUPPL-9	Labeling		Label is not available on this site.
03/23/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/17/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/10/1995	SUPPL-4	Labeling		Label is not available on this site.
01/24/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/29/1993	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072879

AMOXAPINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXAPINE	AMOXAPINE	150MG	TABLET;ORAL	Prescription	No	AB	072879	CHARTWELL RX
AMOXAPINE	AMOXAPINE	150MG	TABLET;ORAL	Prescription	No	AB	072691	WATSON LABS

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXAPINE	AMOXAPINE	25MG	TABLET;ORAL	Prescription	No	AB	072879	CHARTWELL RX
AMOXAPINE	AMOXAPINE	25MG	TABLET;ORAL	Prescription	No	AB	072691	WATSON LABS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXAPINE	AMOXAPINE	50MG	TABLET;ORAL	Prescription	No	AB	072879	CHARTWELL RX
AMOXAPINE	AMOXAPINE	50MG	TABLET;ORAL	Prescription	No	AB	072691	WATSON LABS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXAPINE	AMOXAPINE	100MG	TABLET;ORAL	Prescription	No	AB	072879	CHARTWELL RX
AMOXAPINE	AMOXAPINE	100MG	TABLET;ORAL	Prescription	No	AB	072691	WATSON LABS

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