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Register entryShortage reported

American Regent, Inc.

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Registered sites
5
Drug products
70
Live patents
45
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.

Analytical testingLabellingFinished drug manufacturePackagingRepackaging
Sites

Facilities

5
SiteLocationOperationsFEI
American Regent, Inc.Brea, CAUnited StatesFinished drug manufacture, Repackaging3011148804
American Regent, Inc.Columbus, OHUnited StatesAnalytical testing3003433784
American Regent, Inc.Hilliard, OHUnited StatesFinished drug manufacture3005761472
American Regent, Inc.New Albany, OHUnited StatesLabelling, Finished drug manufacture, Packaging3010209784
American Regent, Inc.Shirley, NYUnited StatesAnalytical testing, Labelling, Finished drug manufacture, Packaging2410375
Alert

Products in shortage

2
DrugPresentationAvailability
Atropine Sulfate InjectionAtropine Sulfate, Injection, 1 mg/1 mL (NDC 0517-1001-25)Available
Atropine Sulfate InjectionAtropine Sulfate, Injection, .4 mg/1 mL (NDC 0517-1004-25)Available
Exclusivity

Patents

45

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

ProductActive ingredientExpiry
INJECTAFERFERRIC CARBOXYMALTOSEJan 2027
INJECTAFERFERRIC CARBOXYMALTOSEFeb 2027
INJECTAFERFERRIC CARBOXYMALTOSEFeb 2028
MULTRYSCUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATEJul 2041
SELENIOUS ACIDSELENIOUS ACIDJul 2041
TRALEMENTCUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATEJul 2041
Catalogue

Marketed products

70

Showing 70 of 70.

BrandGeneric nameFormCategory
AcetylcysteineacetylcysteineINHALANTANDA
AcetylcysteineacetylcysteineINHALANTANDA
AcetylcysteineacetylcysteineINHALANTANDA
AcetylcysteineacetylcysteineINHALANTANDA
Aminocaproic AcidAminocaproic AcidINJECTION, SOLUTIONANDA
Aminocaproic AcidAminocaproic AcidINJECTION, SOLUTIONANDA
Atropine SulfateATROPINE SULFATEINJECTION, SOLUTIONANDA
Atropine SulfateATROPINE SULFATEINJECTION, SOLUTIONANDA
Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateINJECTION, SUSPENSIONANDA
Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateINJECTION, SUSPENSIONANDA
Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateINJECTION, SUSPENSIONANDA
Caffeine and Sodium BenzoateCaffeine and Sodium BenzoateINJECTION, SOLUTIONUNAPPROVED DRUG OTHER
Calcium ChlorideCALCIUM CHLORIDEINJECTION, SOLUTIONANDA
Chlorothiazide SodiumChlorothiazide SodiumINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA
CyanocobalamincyanocobalaminINJECTION, SOLUTIONANDA
CyanocobalamincyanocobalaminINJECTION, SOLUTIONANDA
CyanocobalamincyanocobalaminINJECTION, SOLUTIONANDA
Dicyclomine hydrochlorideDicyclomine hydrochlorideINJECTION, SOLUTIONANDA
DroperidolDroperidolINJECTION, SOLUTIONANDA
ESTRADIOL VALERATEESTRADIOL VALERATEINJECTION, SOLUTIONANDA
ESTRADIOL VALERATEESTRADIOL VALERATEINJECTION, SOLUTIONANDA
EpinephrineepinephrineINJECTIONANDA
GlycopyrrolateGlycopyrrolateINJECTION, SOLUTIONANDA
GlycopyrrolateGlycopyrrolateINJECTION, SOLUTIONANDA
GlycopyrrolateGlycopyrrolateINJECTION, SOLUTIONANDA
GlycopyrrolateGlycopyrrolateINJECTION, SOLUTIONANDA
Gvoke VialDxglucagon injectionINJECTION, SOLUTIONNDA
Hydralazine HydrochlorideHydralazine HydrochlorideINJECTION, SOLUTIONANDA
Hydroxyzine HydrochlorideHydroxyzine HydrochlorideINJECTION, SOLUTIONANDA
Hydroxyzine HydrochlorideHydroxyzine HydrochlorideINJECTION, SOLUTIONANDA
Hydroxyzine HydrochlorideHydroxyzine HydrochlorideINJECTION, SOLUTIONANDA
InjectaferFerric Carboxymaltose InjectionINJECTION, SOLUTIONNDA
InjectaferFerric CarboxymaltoseINJECTION, SOLUTIONNDA
InjectaferFerric Carboxymaltose InjectionINJECTION, SOLUTIONNDA
LevocarnitineLevocarnitineINJECTION, SOLUTIONANDA
LevocarnitineLevocarnitineINJECTION, SOLUTIONANDA
Methylergonovine MaleateMethylergonovine MaleateINJECTION, SOLUTIONANDA
Multitrace -4 PediatricTrace Elements 4INJECTION, SOLUTION, CONCENTRATEUNAPPROVED DRUG OTHER
Multitrace-5Trace Elements 5INJECTION, SOLUTIONUNAPPROVED DRUG OTHER
MultrysTrace Elements Injection 4INJECTION, SOLUTIONNDA
Nicardipine Hydrochloridenicardipine hydrochlorideINJECTION, SOLUTIONANDA
NitroglycerinnitroglycerinINJECTION, SOLUTIONANDA
OlanzapineOlanzapineINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA
PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUNDPaclitaxelINJECTION, POWDER, LYOPHILIZED, FOR SUSPENSIONNDA
PROVAYBLUEmethylene blueINJECTIONNDA
PROVAYBLUEmethylene blueINJECTIONNDA
PROVAYBLUEmethylene blueINJECTIONNDA
PROVAYBLUEmethylene blueINJECTIONNDA
Papaverine HydrochloridePapaverine HydrochlorideINJECTION, SOLUTIONUNAPPROVED DRUG OTHER
Potassium Phosphatespotassium phosphatesINJECTION, SOLUTIONANDA
Potassium PhosphatesPotassium PhosphateINJECTION, SOLUTIONANDA
Potassium PhosphatesPotassium Phosphate, Monobasic Potassium Phosphate, DibasicINJECTION, SOLUTIONANDA
Selenious AcidSelenious AcidINJECTION, SOLUTIONNDA
Selenious AcidSelenious AcidINJECTION, SOLUTIONNDA
Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrousINJECTION, SOLUTIONANDA
Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrousINJECTION, SOLUTIONANDA
Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrousINJECTION, SOLUTIONANDA
Sterile WaterWaterINJECTION, SOLUTIONUNAPPROVED DRUG OTHER
Sterile WaterWaterINJECTION, SOLUTIONUNAPPROVED DRUG OTHER
TralementTrace Elements Injection 4INJECTION, SOLUTIONNDA
VasopressinVasopressinINJECTION, SOLUTIONNDA
VasopressinVasopressinINJECTION, SOLUTIONNDA
Venoferiron sucroseINJECTION, SOLUTIONNDA
Venoferiron sucroseINJECTION, SOLUTIONNDA
Venoferiron sucroseINJECTION, SOLUTIONNDA
Zinc SulfateZinc SulfateINJECTION, SOLUTIONNDA
Zinc SulfateZinc SulfateINJECTION, SOLUTIONNDA
Zinc SulfateZinc SulfateINJECTION, SOLUTIONNDA
epinephrineepinephrineINJECTION, SOLUTIONANDA
fomepizolefomepizoleINJECTION, SOLUTIONANDA
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.