Is Alk-Abello, Inc. FDA approved?

Alk-Abello, Inc. holds 3 FDA-registered establishments across 3 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Alk-Abello, Inc.'s drugs manufactured?

At registered sites in Denmark, Spain, the United States. The FDA register lists Horsholm; MADRID; Port Washington, NY. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does Alk-Abello, Inc. make?

412 products are listed under Alk-Abello, Inc. in the openFDA NDC Directory, most often as injection, solution; solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Alk-Abello, Inc.

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 3
Active NDC listings: 412
Labeller names: 3
Live patents: 8
Countries: 3
Base: United States

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture1Labelling1Finished drug manufacture2Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Alk-abello A/s	Boge Alle 6-8, Horsholm, DK 2970, Denmark (DNK)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3002806343306020926
ALK-ABELLO S.A.	CALLE MIGUEL FLETA 19, MADRID, 28037, Spain (ESP)	Analytical testing	3012749590462218199
Alk-abello, Inc.Registrant: Alk-Abello, Inc.	35 Channel Drive, Port Washington, New York (NY) 11050-2216, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	2431784809998847

Catalogue

Drug listings by form and route

412

412 active NDC listings: 378 non-standardized allergenic, 31 standardized allergenic, 3 human prescription drug. By marketing category: BLA 412.

Dosage form	NDCs
injection, solution	399
solution	11
injection	1
tablet	1

Route	NDCs
subcutaneous	215
percutaneous	205
intradermal	2
sublingual	1

Labeller name on the listing	NDCs
alk-abello, inc.	410
alk-abello a s	1
alk-abello, inc.	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11369566	OTIPRIOciprofloxacin	product	Apr 2029
9205048	OTIPRIOciprofloxacin	use	Apr 2029
9603796	OTIPRIOciprofloxacin	substance, product	Apr 2029
9233068	OTIPRIOciprofloxacin	product	Dec 2029
8318817	OTIPRIOciprofloxacin	use	Apr 2030
9220796	OTIPRIOciprofloxacin	product	Jul 2035
11040004	OTIPRIOciprofloxacin	use	Nov 2037
11246863	OTIPRIOciprofloxacin	product	Nov 2038

Catalogue

Marketed products

412

Showing 150 of 412.

Brand	Generic name	Form / route	NDC
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, subcutaneous	0268-8000BLA
4 WEED MIX	AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN	injection, solution, subcutaneous	0268-8002BLA
4 WEED MIX	AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN and XANTHIUM STRUMARIUM POLLEN	injection, solution, subcutaneous	0268-8003BLA
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, percutaneous	0268-8019BLA
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, subcutaneous	0268-8020BLA
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, subcutaneous	0268-8021BLA
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, subcutaneous	0268-8022BLA
ACACIA	Acacia	injection, solution, subcutaneous	0268-1001BLA
ACACIA	Acacia	injection, solution, percutaneous	0268-6600BLA
ACER NEGUNDO POLLEN	Box Elder Ash Leaf Maple	injection, solution, subcutaneous	0268-1080BLA
ACER NEGUNDO POLLEN	Box Elder Ash Leaf Maple	injection, solution, subcutaneous	0268-1081BLA
ACER NEGUNDO POLLEN	Box Elder Ash Leaf Maple	injection, solution, percutaneous	0268-6612BLA
ACER RUBRUM POLLEN	Maple Red	injection, solution, subcutaneous	0268-1249BLA
ACER RUBRUM POLLEN	Red Maple	injection, solution, percutaneous	0268-6634BLA
ACER SACCHARUM POLLEN	Maple Sugar	injection, solution, subcutaneous	0268-1252BLA
ACER SACCHARUM POLLEN	Maple Sugar	injection, solution, subcutaneous	0268-1253BLA
ACER SACCHARUM POLLEN	Maple Sugar	injection, solution, subcutaneous	0268-1254BLA
ACER SACCHARUM POLLEN	Sugar Maple	injection, solution, percutaneous	0268-6635BLA
ALMOND	PRUNUS DULCIS	injection, solution, percutaneous	0268-6100BLA
ALNUS INCANA SSP RUGOSA POLLEN	Alder White	injection, solution, subcutaneous	0268-1007BLA
ALNUS INCANA SSP RUGOSA POLLEN	Alder White	injection, solution, subcutaneous	0268-1008BLA
ALNUS INCANA SSP RUGOSA POLLEN	White Alder	injection, solution, percutaneous	0268-6601BLA
ALTERNARIA ALTERNATA	ALTERNARIA ALTERNATA	injection, solution, subcutaneous	0268-8082BLA
ALTERNARIA ALTERNATA	ALTERNARIA ALTERNATA	injection, solution, percutaneous, subcutaneous	0268-8083BLA
AMARANTHUS PALMERI POLLEN	Carelessweed	injection, solution, subcutaneous	0268-1092BLA
AMARANTHUS PALMERI POLLEN	Carelessweed	injection, solution, subcutaneous	0268-1093BLA
AMARANTHUS PALMERI POLLEN	Carelessweed	injection, solution, percutaneous	0268-6613BLA
AMARANTHUS RETROFLEXUS POLLEN	Pigweed Rough Redroot	injection, solution, subcutaneous	0268-1364BLA
AMARANTHUS RETROFLEXUS POLLEN	Pigweed Rough Redroot	injection, solution, subcutaneous	0268-1365BLA
AMARANTHUS RETROFLEXUS POLLEN	Rough Pigweed	injection, solution, percutaneous	0268-6649BLA
AMARANTHUS SPINOSUS POLLEN	Pigweed Spiny	injection, solution, subcutaneous	0268-1371BLA
AMARANTHUS SPINOSUS POLLEN	Pigweed Spiny	injection, solution, subcutaneous	0268-1372BLA
AMARANTHUS SPINOSUS POLLEN	Spiny Pigweed	injection, solution, percutaneous	0268-6744BLA
AMARANTHUS TUBERCULATUS POLLEN	Water Hemp	injection, solution, subcutaneous	0268-1519BLA
AMARANTHUS TUBERCULATUS POLLEN	Water Hemp	injection, solution, percutaneous	0268-6771BLA
AMBROSIA ACANTHICARPA POLLEN	Ragweed False Bur	injection, solution, subcutaneous	0268-1424BLA
AMBROSIA ACANTHICARPA POLLEN	False Ragweed Bur	injection, solution, percutaneous	0268-6749BLA
AMBROSIA ARTEMISIIFOLIA POLLEN	Ragweed Short	injection, solution, subcutaneous	0268-1531BLA
AMBROSIA ARTEMISIIFOLIA POLLEN	Ragweed Short	injection, solution, subcutaneous	0268-1532BLA
AMBROSIA PSILOSTACHYA POLLEN	Ragweed Western	injection, solution, subcutaneous	0268-1445BLA
AMBROSIA PSILOSTACHYA POLLEN	Ragweed Western	injection, solution, subcutaneous	0268-1446BLA
AMBROSIA PSILOSTACHYA POLLEN	Western Ragweed	injection, solution, percutaneous	0268-6752BLA
AMBROSIA TRIFIDA POLLEN	Ragweed Tall Giant	injection, solution, subcutaneous	0268-1439BLA
AMBROSIA TRIFIDA POLLEN	Ragweed Tall Giant	injection, solution, subcutaneous	0268-1440BLA
AMBROSIA TRIFIDA POLLEN	Tall Ragweed Giant	injection, solution, percutaneous	0268-6658BLA
APPLE	MALUS DOMESTICA	injection, solution, percutaneous	0268-6101BLA
APRICOT	PRUNUS ARMENIACA	injection, solution, percutaneous	0268-6102BLA
ARTEMISIA TRIDENTATA POLLEN	Sagebrush Common	injection, solution, subcutaneous	0268-1471BLA
ARTEMISIA TRIDENTATA POLLEN	Sagebrush Common	injection, solution, subcutaneous	0268-1472BLA
ARTEMISIA TRIDENTATA POLLEN	Common Sagebrush	injection, solution, percutaneous	0268-6670BLA
ARTEMISIA VULGARIS POLLEN	Mugwort Common	injection, solution, subcutaneous	0268-1297BLA
ARTEMISIA VULGARIS POLLEN	Mugwort Common	injection, solution, subcutaneous	0268-1298BLA
ARTEMISIA VULGARIS POLLEN	Common Mugwort	injection, solution, percutaneous	0268-6639BLA
ASPARAGUS	ASPARAGUS OFFICINALIS	injection, solution, percutaneous	0268-6103BLA
ASPERGILLUS FUMIGATUS	ASPERGILLUS FUMIGATUS	injection, solution, subcutaneous	0268-8084BLA
ASPERGILLUS FUMIGATUS	ASPERGILLUS FUMIGATUS	injection, solution, percutaneous, subcutaneous	0268-8085BLA
AUREOBASIDIUM PULLULANS	AUREOBASIDIUM PULLULANS VAR. PULLUTANS	injection, solution, subcutaneous	0268-8086BLA
AUREOBASIDIUM PULLULANS	AUREOBASIDIUM PULLULANS VAR. PULLUTANS	injection, solution, percutaneous	0268-8087BLA
AVOCADO	PERSEA AMERICANA	injection, solution, percutaneous	0268-6104BLA
BANANA	MUSA SAPIENTUM	injection, solution, percutaneous	0268-6105BLA
BARLEY	HORDEUM VULGARE	injection, solution, percutaneous	0268-6106BLA
BEEF	BOS TAURUS	injection, solution, percutaneous	0268-6109BLA
BELL PEPPER	CAPSICUM ANNUUM	injection, solution, percutaneous	0268-6197BLA
BETULA LENTA POLLEN	Birch Black	injection, solution, subcutaneous	0268-1056BLA
BETULA LENTA POLLEN	Birch White	injection, solution, subcutaneous	0268-1069BLA
BETULA LENTA POLLEN	Birch White	injection, solution, subcutaneous	0268-1070BLA
BETULA LENTA POLLEN	Black Birch	injection, solution, percutaneous	0268-6608BLA
BETULA LENTA POLLEN	White Birch	injection, solution, percutaneous	0268-6610BLA
BETULA NIGRA POLLEN	Birch River Red	injection, solution, subcutaneous	0268-1062BLA
BETULA NIGRA POLLEN	Birch River Red	injection, solution, subcutaneous	0268-1063BLA
BETULA NIGRA POLLEN	River Birch Red	injection, solution, percutaneous	0268-6609BLA
BIPOLARIS SOROKINIANA	COCHLIOBOLUS SATIVUS	injection, solution, subcutaneous	0268-8088BLA
BIPOLARIS SOROKINIANA	COCHLIOBOLUS SATIVUS	injection, solution, percutaneous, subcutaneous	0268-8089BLA
BIRCH MIX	BETULA NIGRA POLLEN and BETULA POPULIFOLIA POLLEN	injection, solution, percutaneous	0268-8024BLA
BLACK PEPPER	PIPER NIGRUM	injection, solution, percutaneous	0268-6198BLA
BLATELLA GERMANICA	GERMAN COCKROACH	injection, solution, subcutaneous	0268-0714BLA
BLATELLA GERMANICA	German Cockroach	injection, solution, percutaneous	0268-6405BLA
BOS TAURUS SKIN	CATTLE EPITHELIA	injection, solution, subcutaneous	0268-0603BLA
BOS TAURUS SKIN	Cattle Epithelium	injection, solution, percutaneous	0268-6300BLA
BOTRYTIS CINEREA	BOTRYTIS CINEREA	injection, solution, subcutaneous	0268-8090BLA
BOTRYTIS CINEREA	BOTRYTIS CINEREA	injection, solution, percutaneous, subcutaneous	0268-8091BLA
BRAZIL NUT	BERTHOLLETIA EXCELSA	injection, solution, percutaneous	0268-6110BLA
BROCCOLI	BRASSICA OLERACEA VAR. BOTRYTIS	injection, solution, percutaneous	0268-6112BLA
BROMUS INERMIS POLLEN	Brome Grass	injection, solution, subcutaneous	0268-1087BLA
BROMUS INERMIS POLLEN	Brome Grass	injection, solution, percutaneous	0268-6691BLA
BUCKWHEAT	FAGOPYRUM ESCULENTUM	injection, solution, percutaneous	0268-6113BLA
Bermuda Grass, Standardized	Bermuda Grass, Standardized	injection, solution, subcutaneous	0268-0293BLA
Bermuda Grass, Standardized	Bermuda Grass, Standardized	solution, percutaneous	0268-3050BLA
CABBAGE	BRASSICA OLERACEA VAR. CAPITATA	injection, solution, percutaneous	0268-6114BLA
CANDIDA ALBICANS	CANDIDA ALBICANS	injection, solution, subcutaneous	0268-8092BLA
CANDIDA ALBICANS	CANDIDA ALBICANS	injection, solution, percutaneous	0268-8093BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	injection, solution, subcutaneous	0268-0615BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	injection, solution, subcutaneous	0268-0619BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	injection, solution, subcutaneous	0268-0620BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	injection, solution, subcutaneous	0268-0621BLA
CANIS LUPUS FAMILIARIS SKIN	DOG EPITHELIA	injection, solution, subcutaneous	0268-0626BLA
CANIS LUPUS FAMILIARIS SKIN	Dog Epithelium	injection, solution, percutaneous	0268-6306BLA
CANTALOUPE	CUCUMIS MELO CANTALUPENSIS	injection, solution, percutaneous	0268-6115BLA
CARROT	DAUCUS CAROTA	injection, solution, percutaneous	0268-6116BLA
CARYA ILLINOINENSIS POLLEN	Pecan Pollen	injection, solution, subcutaneous	0268-1354BLA
CARYA ILLINOINENSIS POLLEN	Pecan Pollen	injection, solution, subcutaneous	0268-1355BLA
CARYA ILLINOINENSIS POLLEN	Pecan Pollen	injection, solution, percutaneous	0268-6648BLA
CARYA OVATA POLLEN	Shagbark Hickory	injection, solution, percutaneous	0268-6627BLA
CASEIN	BOS TAURUS	injection, solution, percutaneous	0268-6118BLA
CASUARINA EQUISETIFOLIA POLLEN	Pine Australian Beefwood	injection, solution, subcutaneous	0268-1376BLA
CAVIA PORCELLUS SKIN	GUINEA PIG EPITHELIA	injection, solution, subcutaneous	0268-0653BLA
CAVIA PORCELLUS SKIN	Guinea Pig Epithelium	injection, solution, percutaneous	0268-6309BLA
CELERY	APIUM GRAVEOLENS	injection, solution, percutaneous	0268-6120BLA
CELTIS OCCIDENTALIS POLLEN	Hackberry	injection, solution, subcutaneous	0268-1198BLA
CELTIS OCCIDENTALIS POLLEN	Hackberry	injection, solution, subcutaneous	0268-1199BLA
CELTIS OCCIDENTALIS POLLEN	Hackberry	injection, solution, percutaneous	0268-6626BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	injection, solution, subcutaneous	0268-1238BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	injection, solution, subcutaneous	0268-1239BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	injection, solution, subcutaneous	0268-1240BLA
CHENOPODIUM ALBUM POLLEN	Lambs Quarters	injection, solution, percutaneous	0268-6632BLA
CHERRY	PRUNUS AVIUM	injection, solution, percutaneous	0268-6121BLA
CHICKEN MEAT	GALLUS GALLUS	injection, solution, percutaneous	0268-6122BLA
CINNAMON	CINNAMOMUM VERUM	injection, solution, percutaneous	0268-6123BLA
CLADOSPORIUM CLADOSPORIOIDES	CLADOSPORIUM CLADOSPORIOIDES	injection, solution, subcutaneous	0268-8094BLA
CLADOSPORIUM CLADOSPORIOIDES	CLADOSPORIUM CLADOSPORIOIDES	injection, solution, percutaneous, subcutaneous	0268-8095BLA
CLAM	MERCENARIA MERCENARIA	injection, solution, percutaneous	0268-6124BLA
COCOA BEAN	THEOBROMA CACAO	injection, solution, percutaneous	0268-6125BLA
COCONUT	COCOS NUCIFERA	injection, solution, percutaneous	0268-6127BLA
CODFISH	GADUS MORHUA	injection, solution, percutaneous	0268-6128BLA
COFFEE	COFFEE ARABICA	injection, solution, percutaneous	0268-6129BLA
COWS MILK	BOS TAURUS	injection, solution, percutaneous	0268-6178BLA
CRAB	PARALITHODES CAMTSCHATICUS	injection, solution, percutaneous	0268-6130BLA
CUCUMBER	CUCUMIS SATIVUS	injection, solution, percutaneous	0268-6132BLA
CUPRESSUS ARIZONICA POLLEN	Cypress Arizona	injection, solution, subcutaneous	0268-1143BLA
CUPRESSUS ARIZONICA POLLEN	Arizona Cypress	injection, solution, percutaneous	0268-6619BLA
Cat Hair, Standardized	Cat Hair, Standardized	injection, solution, subcutaneous	0268-2000BLA
Cat Hair, Standardized	Cat Hair, Standardized	solution, percutaneous	0268-2001BLA
DANDELION	TARAXACUM OFFICINALE POLLEN	injection, solution, subcutaneous	0268-7100BLA
EGG WHITE	GALLUS GALLUS	injection, solution, percutaneous	0268-6133BLA
EGG YOLK	GALLUS GALLUS	injection, solution, percutaneous	0268-6136BLA
EGG, WHOLE	GALLUS GALLUS	injection, solution, percutaneous	0268-6135BLA
ELYMUS REPENS POLLEN	Quack Grass	injection, solution, subcutaneous	0268-1418BLA
ENGLISH WALNUT	JUGLANS REGIA	injection, solution, percutaneous	0268-6231BLA
EPICOCCUM NIGRUM	EPICOCCUM NIGRUM	injection, solution, subcutaneous	0268-8096BLA
EPICOCCUM NIGRUM	EPICOCCUM NIGRUM	injection, solution, percutaneous, subcutaneous	0268-8097BLA
EQUUS CABALLUS SKIN	HORSE EPITHELIA	injection, solution, subcutaneous	0268-0628BLA
EQUUS CABALLUS SKIN	HORSE EPITHELIA	injection, solution, subcutaneous	0268-0631BLA
EQUUS CABALLUS SKIN	Horse Epithelium	injection, solution, percutaneous	0268-6311BLA
EUCALYPTUS GLOBULUS POLLEN	Eucalyptus	injection, solution, subcutaneous	0268-1185BLA
EUCALYPTUS GLOBULUS POLLEN	Eucalyptus	injection, solution, subcutaneous	0268-1186BLA
EUCALYPTUS GLOBULUS POLLEN	Eucalyptus	injection, solution, percutaneous	0268-6712BLA
EUPATORIUM CAPILLIFOLIUM POLLEN	Dog Fennel Non Stock	injection, solution, subcutaneous	0268-1165BLA
EUPATORIUM CAPILLIFOLIUM POLLEN	Dog Fennel	injection, solution, percutaneous	0268-6706BLA
FAGUS GRANDIFOLIA POLLEN	Beech	injection, solution, subcutaneous	0268-1046BLA
FAGUS GRANDIFOLIA POLLEN	Beech	injection, solution, subcutaneous	0268-1047BLA

Neighbours

Registered in the same town

Eli Lilly and CompanyMadrid, ESP
ROVI Pharma Industrial Services S.A.Madrid, ESP
LABORATORIOS FARMACEUTICOS ROVI S.A.Madrid, ESP
Moderna US, Inc.MADRID, ESP

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Enquiry

Common questions

Is Alk-Abello, Inc. FDA approved?: Alk-Abello, Inc. holds 3 FDA-registered establishments across 3 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Alk-Abello, Inc.'s drugs manufactured?: At registered sites in Denmark, Spain, the United States. The FDA register lists Horsholm; MADRID; Port Washington, NY. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does Alk-Abello, Inc. make?: 412 products are listed under Alk-Abello, Inc. in the openFDA NDC Directory, most often as injection, solution; solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.