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Register entryShortage reported

Elite Laboratories, Inc.

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Registered sites
1
Drug products
54
Live patents
0
Countries
1
Base
United States
Authorisation

Registered operations

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

LabellingFinished drug manufacture
Sites

Facilities

1
SiteLocationOperationsFEI
Elite Laboratories, Inc.Northvale, NJUnited StatesLabelling, Finished drug manufacture3002644678
Alert

Products in shortage

14
DrugPresentationAvailability
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 64850-505-01)Available
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 64850-503-01)Available
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 64850-500-01)Available
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 64850-506-01)Available
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 64850-502-01)Available
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 64850-504-01)Available
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 64850-501-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 64850-556-01)Limited Availability
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 64850-552-01)Limited Availability
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 64850-555-01)Limited Availability
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 64850-550-01)Limited Availability
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 64850-551-01)Limited Availability
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 64850-554-01)Limited Availability
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 64850-553-01)Limited Availability
Catalogue

Marketed products

54

Showing 54 of 54.

BrandGeneric nameFormCategory
Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTABLETANDA
Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTABLETANDA
Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTABLETANDA
Dantrolene Sodiumdantrolene sodiumCAPSULEANDA
Dantrolene Sodiumdantrolene sodiumCAPSULEANDA
Dantrolene Sodiumdantrolene sodiumCAPSULEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
IsradipineIsradipineCAPSULEANDA
IsradipineIsradipineCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCAPSULEANDA
LoxapineLoxapineCAPSULEANDA
LoxapineLoxapineCAPSULEANDA
LoxapineLoxapineCAPSULEANDA
LoxapineLoxapineCAPSULEANDA
Methadone HydrochlorideMethadone HydrochlorideTABLETANDA
Methadone HydrochlorideMethadone HydrochlorideTABLETANDA
Methotrexate SodiumMethotrexate SodiumTABLETANDA
Naltrexone HydrochlorideNaltrexone HydrochlorideTABLET, FILM COATEDANDA
Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenTABLETANDA
Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenTABLETANDA
Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenTABLETANDA
PHENDIMETRAZINE TARTRATEPhendimetrazine TartrateTABLETANDA
PT Elite Premium Pain ReliefCAPSAICIN, MENTHOLCREAMOTC MONOGRAPH DRUG
Phentermine HydrochloridePhentermine HydrochlorideTABLETANDA
RopiniroleRopiniroleTABLET, EXTENDED RELEASEANDA
RopiniroleRopiniroleTABLET, EXTENDED RELEASEANDA
RopiniroleRopiniroleTABLET, EXTENDED RELEASEANDA
RopiniroleRopiniroleTABLET, EXTENDED RELEASEANDA
RopiniroleRopiniroleTABLET, EXTENDED RELEASEANDA
Trimipramine MaleateTrimipramine MaleateCAPSULEANDA
Trimipramine MaleateTrimipramine MaleateCAPSULEANDA
Trimipramine MaleateTrimipramine MaleateCAPSULEANDA
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.