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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074007
Company: ANI PHARMS

Products on ANDA 074007

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074007

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/1995	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
11/07/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
07/25/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
07/15/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/2000	SUPPL-4	Labeling		Label is not available on this site.
11/10/1999	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/05/1998	SUPPL-2	Labeling		Label is not available on this site.
06/08/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074007

ACEBUTOLOL HYDROCHLORIDE

CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	075047	AMNEAL PHARM
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	074007	ANI PHARMS

CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE;ORAL	Prescription	No	AB	075047	AMNEAL PHARM
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE;ORAL	Prescription	No	AB	074007	ANI PHARMS

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