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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018917
Company: PROMIUS PHARMA

Products on NDA 018917

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SECTRAL	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
SECTRAL	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018917

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.

Labels for NDA 018917

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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