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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075047
Company: AMNEAL PHARM

Products on ANDA 075047

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	Yes
ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075047

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075047Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/21/2011	SUPPL-9	Labeling		Label is not available on this site.
04/06/2015	SUPPL-7	Labeling		Label is not available on this site.
05/22/2007	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
05/22/2007	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/22/2007	SUPPL-3	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.

Therapeutic Equivalents for ANDA 075047

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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