Drugs@FDA: FDA Approved Drug Products

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

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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