Alk-Abello, Inc.

Registered sites: 3
Drug products: 412
Live patents: 8
Countries: 3
Base: United States

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingRelabellingRepackaging

Sites

Facilities

Site	Location	Operations	FEI
Alk-abello A/s	HorsholmDenmark	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3002806343
ALK-ABELLO S.A.	MADRIDSpain	Analytical testing	3012749590
Alk-abello, Inc.	Port Washington, NYUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	2431784

Exclusivity

Patents

Unexpired Orange Book patents where this company is the application holder.

Product	Active ingredient	Expiry
OTIPRIO	CIPROFLOXACIN	Apr 2029
OTIPRIO	CIPROFLOXACIN	Dec 2029
OTIPRIO	CIPROFLOXACIN	Apr 2030
OTIPRIO	CIPROFLOXACIN	Jul 2035
OTIPRIO	CIPROFLOXACIN	Nov 2037
OTIPRIO	CIPROFLOXACIN	Nov 2038

Catalogue

Marketed products

412

Showing 150 of 412.

Brand	Generic name	Form	Category
10 TREE MIX	ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN and ULMUS AMERICANA POLLEN	INJECTION, SOLUTION	BLA
4 WEED MIX	AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN	INJECTION, SOLUTION	BLA
4 WEED MIX	AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN and XANTHIUM STRUMARIUM POLLEN	INJECTION, SOLUTION	BLA
9 TREE MIX	ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN and ULMUS CRASSIFOLIA POLLEN	INJECTION, SOLUTION	BLA
9 TREE MIX	ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS AMERICANA POLLEN	INJECTION, SOLUTION	BLA
9 TREE MIX	ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS CRASSIFOLIA POLLEN	INJECTION, SOLUTION	BLA
9 TREE MIX	ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN and ULMUS CRASSIFOLIA POLLEN	INJECTION, SOLUTION	BLA
ACACIA	Acacia	INJECTION, SOLUTION	BLA
ACACIA	Acacia	INJECTION, SOLUTION	BLA
ACER NEGUNDO POLLEN	Box Elder Ash Leaf Maple	INJECTION, SOLUTION	BLA
ACER NEGUNDO POLLEN	Box Elder Ash Leaf Maple	INJECTION, SOLUTION	BLA
ACER NEGUNDO POLLEN	Box Elder Ash Leaf Maple	INJECTION, SOLUTION	BLA
ACER RUBRUM POLLEN	Maple Red	INJECTION, SOLUTION	BLA
ACER RUBRUM POLLEN	Red Maple	INJECTION, SOLUTION	BLA
ACER SACCHARUM POLLEN	Maple Sugar	INJECTION, SOLUTION	BLA
ACER SACCHARUM POLLEN	Maple Sugar	INJECTION, SOLUTION	BLA
ACER SACCHARUM POLLEN	Maple Sugar	INJECTION, SOLUTION	BLA
ACER SACCHARUM POLLEN	Sugar Maple	INJECTION, SOLUTION	BLA
ALMOND	PRUNUS DULCIS	INJECTION, SOLUTION	BLA
ALNUS INCANA SSP RUGOSA POLLEN	Alder White	INJECTION, SOLUTION	BLA
ALNUS INCANA SSP RUGOSA POLLEN	Alder White	INJECTION, SOLUTION	BLA
ALNUS INCANA SSP RUGOSA POLLEN	White Alder	INJECTION, SOLUTION	BLA
ALTERNARIA ALTERNATA	ALTERNARIA ALTERNATA	INJECTION, SOLUTION	BLA
ALTERNARIA ALTERNATA	ALTERNARIA ALTERNATA	INJECTION, SOLUTION	BLA
AMARANTHUS PALMERI POLLEN	Carelessweed	INJECTION, SOLUTION	BLA
AMARANTHUS PALMERI POLLEN	Carelessweed	INJECTION, SOLUTION	BLA
AMARANTHUS PALMERI POLLEN	Carelessweed	INJECTION, SOLUTION	BLA
AMARANTHUS RETROFLEXUS POLLEN	Pigweed Rough Redroot	INJECTION, SOLUTION	BLA
AMARANTHUS RETROFLEXUS POLLEN	Pigweed Rough Redroot	INJECTION, SOLUTION	BLA
AMARANTHUS RETROFLEXUS POLLEN	Rough Pigweed	INJECTION, SOLUTION	BLA
AMARANTHUS SPINOSUS POLLEN	Pigweed Spiny	INJECTION, SOLUTION	BLA
AMARANTHUS SPINOSUS POLLEN	Pigweed Spiny	INJECTION, SOLUTION	BLA
AMARANTHUS SPINOSUS POLLEN	Spiny Pigweed	INJECTION, SOLUTION	BLA
AMARANTHUS TUBERCULATUS POLLEN	Water Hemp	INJECTION, SOLUTION	BLA
AMARANTHUS TUBERCULATUS POLLEN	Water Hemp	INJECTION, SOLUTION	BLA
AMBROSIA ACANTHICARPA POLLEN	Ragweed False Bur	INJECTION, SOLUTION	BLA
AMBROSIA ACANTHICARPA POLLEN	False Ragweed Bur	INJECTION, SOLUTION	BLA
AMBROSIA ARTEMISIIFOLIA POLLEN	Ragweed Short	INJECTION, SOLUTION	BLA
AMBROSIA ARTEMISIIFOLIA POLLEN	Ragweed Short	INJECTION, SOLUTION	BLA
AMBROSIA PSILOSTACHYA POLLEN	Ragweed Western	INJECTION, SOLUTION	BLA
AMBROSIA PSILOSTACHYA POLLEN	Ragweed Western	INJECTION, SOLUTION	BLA
AMBROSIA PSILOSTACHYA POLLEN	Western Ragweed	INJECTION, SOLUTION	BLA
AMBROSIA TRIFIDA POLLEN	Ragweed Tall Giant	INJECTION, SOLUTION	BLA
AMBROSIA TRIFIDA POLLEN	Ragweed Tall Giant	INJECTION, SOLUTION	BLA
AMBROSIA TRIFIDA POLLEN	Tall Ragweed Giant	INJECTION, SOLUTION	BLA
APPLE	MALUS DOMESTICA	INJECTION, SOLUTION	BLA
APRICOT	PRUNUS ARMENIACA	INJECTION, SOLUTION	BLA
ARTEMISIA TRIDENTATA POLLEN	Sagebrush Common	INJECTION, SOLUTION	BLA
ARTEMISIA TRIDENTATA POLLEN	Sagebrush Common	INJECTION, SOLUTION	BLA
ARTEMISIA TRIDENTATA POLLEN	Common Sagebrush	INJECTION, SOLUTION	BLA
ARTEMISIA VULGARIS POLLEN	Mugwort Common	INJECTION, SOLUTION	BLA
ARTEMISIA VULGARIS POLLEN	Mugwort Common	INJECTION, SOLUTION	BLA
ARTEMISIA VULGARIS POLLEN	Common Mugwort	INJECTION, SOLUTION	BLA
ASPARAGUS	ASPARAGUS OFFICINALIS	INJECTION, SOLUTION	BLA
ASPERGILLUS FUMIGATUS	ASPERGILLUS FUMIGATUS	INJECTION, SOLUTION	BLA
ASPERGILLUS FUMIGATUS	ASPERGILLUS FUMIGATUS	INJECTION, SOLUTION	BLA
AUREOBASIDIUM PULLULANS	AUREOBASIDIUM PULLULANS VAR. PULLUTANS	INJECTION, SOLUTION	BLA
AUREOBASIDIUM PULLULANS	AUREOBASIDIUM PULLULANS VAR. PULLUTANS	INJECTION, SOLUTION	BLA
AVOCADO	PERSEA AMERICANA	INJECTION, SOLUTION	BLA
BANANA	MUSA SAPIENTUM	INJECTION, SOLUTION	BLA
BARLEY	HORDEUM VULGARE	INJECTION, SOLUTION	BLA
BEEF	BOS TAURUS	INJECTION, SOLUTION	BLA
BELL PEPPER	CAPSICUM ANNUUM	INJECTION, SOLUTION	BLA
BETULA LENTA POLLEN	Birch Black	INJECTION, SOLUTION	BLA
BETULA LENTA POLLEN	Birch White	INJECTION, SOLUTION	BLA
BETULA LENTA POLLEN	Birch White	INJECTION, SOLUTION	BLA
BETULA LENTA POLLEN	Black Birch	INJECTION, SOLUTION	BLA
BETULA LENTA POLLEN	White Birch	INJECTION, SOLUTION	BLA
BETULA NIGRA POLLEN	Birch River Red	INJECTION, SOLUTION	BLA
BETULA NIGRA POLLEN	Birch River Red	INJECTION, SOLUTION	BLA
BETULA NIGRA POLLEN	River Birch Red	INJECTION, SOLUTION	BLA
BIPOLARIS SOROKINIANA	COCHLIOBOLUS SATIVUS	INJECTION, SOLUTION	BLA
BIPOLARIS SOROKINIANA	COCHLIOBOLUS SATIVUS	INJECTION, SOLUTION	BLA
BIRCH MIX	BETULA NIGRA POLLEN and BETULA POPULIFOLIA POLLEN	INJECTION, SOLUTION	BLA
BLACK PEPPER	PIPER NIGRUM	INJECTION, SOLUTION	BLA
BLATELLA GERMANICA	GERMAN COCKROACH	INJECTION, SOLUTION	BLA
BLATELLA GERMANICA	German Cockroach	INJECTION, SOLUTION	BLA
BOS TAURUS SKIN	CATTLE EPITHELIA	INJECTION, SOLUTION	BLA
BOS TAURUS SKIN	Cattle Epithelium	INJECTION, SOLUTION	BLA
BOTRYTIS CINEREA	BOTRYTIS CINEREA	INJECTION, SOLUTION	BLA
BOTRYTIS CINEREA	BOTRYTIS CINEREA	INJECTION, SOLUTION	BLA
BRAZIL NUT	BERTHOLLETIA EXCELSA	INJECTION, SOLUTION	BLA
BROCCOLI	BRASSICA OLERACEA VAR. BOTRYTIS	INJECTION, SOLUTION	BLA
BROMUS INERMIS POLLEN	Brome Grass	INJECTION, SOLUTION	BLA
BROMUS INERMIS POLLEN	Brome Grass	INJECTION, SOLUTION	BLA
BUCKWHEAT	FAGOPYRUM ESCULENTUM	INJECTION, SOLUTION	BLA
Bermuda Grass, Standardized	Bermuda Grass, Standardized	INJECTION, SOLUTION	BLA
Bermuda Grass, Standardized	Bermuda Grass, Standardized	SOLUTION	BLA
CABBAGE	BRASSICA OLERACEA VAR. CAPITATA	INJECTION, SOLUTION	BLA
CANDIDA ALBICANS	CANDIDA ALBICANS	INJECTION, SOLUTION	BLA
CANDIDA ALBICANS	CANDIDA ALBICANS	INJECTION, SOLUTION	BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	INJECTION, SOLUTION	BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	INJECTION, SOLUTION	BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	INJECTION, SOLUTION	BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	INJECTION, SOLUTION	BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	INJECTION, SOLUTION	BLA
CANIS LUPUS FAMILIARIS SKIN	Dog Epithelium	INJECTION, SOLUTION	BLA
CANTALOUPE	CUCUMIS MELO CANTALUPENSIS	INJECTION, SOLUTION	BLA
CARROT	DAUCUS CAROTA	INJECTION, SOLUTION	BLA
CARYA ILLINOINENSIS POLLEN	Pecan Pollen	INJECTION, SOLUTION	BLA
CARYA ILLINOINENSIS POLLEN	Pecan Pollen	INJECTION, SOLUTION	BLA
CARYA ILLINOINENSIS POLLEN	Pecan Pollen	INJECTION, SOLUTION	BLA
CARYA OVATA POLLEN	Shagbark Hickory	INJECTION, SOLUTION	BLA
CASEIN	BOS TAURUS	INJECTION, SOLUTION	BLA
CASUARINA EQUISETIFOLIA POLLEN	Pine Australian Beefwood	INJECTION, SOLUTION	BLA
CAVIA PORCELLUS SKIN	GUINEA PIG EPITHELIA	INJECTION, SOLUTION	BLA
CAVIA PORCELLUS SKIN	Guinea Pig Epithelium	INJECTION, SOLUTION	BLA
CELERY	APIUM GRAVEOLENS	INJECTION, SOLUTION	BLA
CELTIS OCCIDENTALIS POLLEN	Hackberry	INJECTION, SOLUTION	BLA
CELTIS OCCIDENTALIS POLLEN	Hackberry	INJECTION, SOLUTION	BLA
CELTIS OCCIDENTALIS POLLEN	Hackberry	INJECTION, SOLUTION	BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	INJECTION, SOLUTION	BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	INJECTION, SOLUTION	BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	INJECTION, SOLUTION	BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	INJECTION, SOLUTION	BLA
CHERRY	PRUNUS AVIUM	INJECTION, SOLUTION	BLA
CHICKEN MEAT	GALLUS GALLUS	INJECTION, SOLUTION	BLA
CINNAMON	CINNAMOMUM VERUM	INJECTION, SOLUTION	BLA
CLADOSPORIUM CLADOSPORIOIDES	CLADOSPORIUM CLADOSPORIOIDES	INJECTION, SOLUTION	BLA
CLADOSPORIUM CLADOSPORIOIDES	CLADOSPORIUM CLADOSPORIOIDES	INJECTION, SOLUTION	BLA
CLAM	MERCENARIA MERCENARIA	INJECTION, SOLUTION	BLA
COCOA BEAN	THEOBROMA CACAO	INJECTION, SOLUTION	BLA
COCONUT	COCOS NUCIFERA	INJECTION, SOLUTION	BLA
CODFISH	GADUS MORHUA	INJECTION, SOLUTION	BLA
COFFEE	COFFEE ARABICA	INJECTION, SOLUTION	BLA
COWS MILK	BOS TAURUS	INJECTION, SOLUTION	BLA
CRAB	PARALITHODES CAMTSCHATICUS	INJECTION, SOLUTION	BLA
CUCUMBER	CUCUMIS SATIVUS	INJECTION, SOLUTION	BLA
CUPRESSUS ARIZONICA POLLEN	Cypress Arizona	INJECTION, SOLUTION	BLA
CUPRESSUS ARIZONICA POLLEN	Arizona Cypress	INJECTION, SOLUTION	BLA
Cat Hair, Standardized	Cat Hair, Standardized	INJECTION, SOLUTION	BLA
Cat Hair, Standardized	Cat Hair, Standardized	SOLUTION	BLA
DANDELION	TARAXACUM OFFICINALE POLLEN	INJECTION, SOLUTION	BLA
EGG WHITE	GALLUS GALLUS	INJECTION, SOLUTION	BLA
EGG YOLK	GALLUS GALLUS	INJECTION, SOLUTION	BLA
EGG, WHOLE	GALLUS GALLUS	INJECTION, SOLUTION	BLA
ELYMUS REPENS POLLEN	Quack Grass	INJECTION, SOLUTION	BLA
ENGLISH WALNUT	JUGLANS REGIA	INJECTION, SOLUTION	BLA
EPICOCCUM NIGRUM	EPICOCCUM NIGRUM	INJECTION, SOLUTION	BLA
EPICOCCUM NIGRUM	EPICOCCUM NIGRUM	INJECTION, SOLUTION	BLA
EQUUS CABALLUS SKIN	HORSE EPITHELIA	INJECTION, SOLUTION	BLA
EQUUS CABALLUS SKIN	HORSE EPITHELIA	INJECTION, SOLUTION	BLA
EQUUS CABALLUS SKIN	Horse Epithelium	INJECTION, SOLUTION	BLA
EUCALYPTUS GLOBULUS POLLEN	Eucalyptus	INJECTION, SOLUTION	BLA
EUCALYPTUS GLOBULUS POLLEN	Eucalyptus	INJECTION, SOLUTION	BLA
EUCALYPTUS GLOBULUS POLLEN	Eucalyptus	INJECTION, SOLUTION	BLA
EUPATORIUM CAPILLIFOLIUM POLLEN	Dog Fennel Non Stock	INJECTION, SOLUTION	BLA
EUPATORIUM CAPILLIFOLIUM POLLEN	Dog Fennel	INJECTION, SOLUTION	BLA
FAGUS GRANDIFOLIA POLLEN	Beech	INJECTION, SOLUTION	BLA
FAGUS GRANDIFOLIA POLLEN	Beech	INJECTION, SOLUTION	BLA

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.