Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074288
Company: MYLAN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/24/1995 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
03/28/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/26/2014 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/04/1999 SUPPL-3 Labeling

Label is not available on this site.

06/23/1998 SUPPL-2 Labeling

Label is not available on this site.

02/05/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 074288 MYLAN
SECTRAL ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE;ORAL Prescription Yes AB 018917 PROMIUS PHARMA

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 074288 MYLAN
SECTRAL ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE;ORAL Prescription Yes AB 018917 PROMIUS PHARMA

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