Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074007
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACEBUTOLOL HYDROCHLORIDE ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE;ORAL Discontinued None No No
ACEBUTOLOL HYDROCHLORIDE ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE;ORAL Discontinued None 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
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.

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