Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018917
Company: PROMIUS PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SECTRAL ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE;ORAL Discontinued None Yes No
SECTRAL ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE;ORAL Discontinued None Yes 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
12/28/1984 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018917s025ltr.pdf
09/06/2007 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018917s024_ltr.pdf
07/13/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/22/1999 SUPPL-20 Labeling

Label is not available on this site.

11/07/1997 SUPPL-19 Labeling

Label is not available on this site.

08/10/1989 SUPPL-17 Labeling

Label is not available on this site.

10/03/1988 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/05/1988 SUPPL-15 Labeling

Label is not available on this site.

03/24/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/18/1987 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1987 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/05/1988 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/04/1987 SUPPL-8 Labeling

Label is not available on this site.

06/11/1987 SUPPL-7 Labeling

Label is not available on this site.

06/25/1986 SUPPL-6 Labeling

Label is not available on this site.

06/09/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/03/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf
09/06/2007 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf

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