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ACEBUTOLOL HYDROCHLORIDE

ANDA

ACEBUTOLOL HYDROCHLORIDE | A075047 | AMNEAL PHARMACEUTICAL

2 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 30, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 200MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 30, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 400MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 30, 1999