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SECTRAL

NDA

ACEBUTOLOL HYDROCHLORIDE | N018917 | PROMIUS PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs7 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MOEHS IBERICA SLACEBUTOLOL

DMF 144201999

SS PHARMA LLCACEBUTOLOL HYDROCHLORIDE USP

DMF 358572021

ERREGIERRE SPAInactiveACEBUTOLOL HYDROCHLORIDE

DMF 79901989

QUIMICA SINTETICA SAInactiveACEBUTOLOL HYDROCHLORIDE

DMF 88741990

CAMBREX PROFARMACO MILANO SRLInactiveACEBUTOLOL HYDROCHLORIDE

DMF 93761991

SANOFI CHIMIEInactiveACEBUTOLOL HYDROCHLORIDE

DMF 93821991

LUSOCHIMICA SPAInactiveACEBUTOLOL HYDROCHLORIDE

DMF 94421991

SOLCHEM ITALIANA SPAInactiveACEBUTOLOL HYDROCHLORIDE

DMF 96641992

GENZYME CORPInactiveACEBUTOLOL HYDROCHLORIDE

DMF 99571992

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 7, 2011	SUPPL -25	View Letter (PDF)
Sep 11, 2007	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 28, 1984

No patent or exclusivity listings for this strength.

#003 — EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 28, 1984