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BISOPROLOL FUMARATE

ANDA

BISOPROLOL FUMARATE | A204891 | ALEMBIC PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain13 active DMFs2 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

MERCK KGAABISOPROLOL FUMARATE 2:1

DMF 80241989

CORDEN PHARMA CHENOVEBISOPROLOL FUMARATE

DMF 139101998

MOEHS IBERICA SLBISOPROLOL FUMARATE

DMF 150832000

UNICHEM LABORATORIES LTDBISOPROLOL FUMARATE USP

DMF 163982003

APITORIA PHARMA PRIVATE LTDBISOPROLOL FUMARATE USP

DMF 187812005

TAIWAN BIOTECH CO LTDBISOPROLOL FUMARATE

DMF 201202006

AREVIPHARMA GMBHBISOPROLOL FUMARATE

DMF 232412009

IPCA LABORATORIES LTDBISOPROLOL FUMARATE USP (PROCESS II)

DMF 266672013

PIRAMAL PHARMA LTDBISOPROLOL FUMARATE

DMF 291232015

SUPRIYA LIFESCIENCE LTDBISOPROLOL FUMARATE USP

DMF 356502021

MEDILUX LABORATORIES PVT LTDBISOPROLOL FUMARATE

DMF 358302021

MICRO LABS LTDBISOPROLOL FUMARATE USP

DMF 376012022

MSN PHARMACHEM PRIVATE LTDBISOPROLOL FUMARATE USP

DMF 414262025

CHONGQING LUMMY PHARMACEUTICAL CO LTDInactiveBISOPROLOL FUMARATE USP

DMF 198072006

IPCA LABORATORIES LTDInactiveBISOPROLOL FUMARATE USP

DMF 241202010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 18, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 11, 2017

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 11, 2017