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Register entryShortage reported

Amphastar France Pharmaceuticals

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Registered sites
2
Drug products
23
Live patents
3
Countries
2
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) manufacturedistributeLabellingFinished drug manufacturePackaging
Sites

Facilities

2
SiteLocationOperationsFEI
Amphastar France PharmaceuticalsEragny-Sur-EpteFranceAnalytical testing, Active ingredient (API) manufacture3003672088
Amphastar Pharmaceuticals, Inc.Rancho Cucamonga, CAUnited StatesAnalytical testing, distribute, Labelling, Finished drug manufacture, Packaging3002936358
Alert

Products in shortage

6
DrugPresentationAvailability
Atropine Sulfate InjectionAtropine Sulfate, Injection, .1 mg/1 mL (NDC 76329-3340-1)Available
Dextrose Monohydrate 50% InjectionDextrose Monohydrate 50%, Injection, 25 g/50 mL (NDC 76329-3302-1)Available
Lidocaine Hydrochloride InjectionLidocaine Hydrochloride, Injection, 20 mg/1 mL (NDC 76329-3390-1)Limited Availability
Lorazepam InjectionLorazepam, Injection, 2 mg/1 mL (NDC 76329-8261-1)Available
Morphine Sulfate InjectionMorphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1)Available
Sodium Bicarbonate InjectionSodium Bicarbonate, Injection, 84 mg/1 mL (NDC 76329-3352-1)Limited Availability
Exclusivity

Patents

3

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

ProductActive ingredientExpiry
BAQSIMIGLUCAGONFeb 2036
BAQSIMIGLUCAGONSept 2039
Catalogue

Marketed products

23

Showing 23 of 23.

BrandGeneric nameFormCategory
AMPHADASEhyaluronidaseINJECTIONBLA
BaqsimiglucagonPOWDERNDA
BaqsimiglucagonPOWDERNDA
CortrosynCosyntropinINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin SodiumEnoxaparin sodiumINJECTIONANDA
Enoxaparin Sodiumenoxaparin sodiumINJECTIONANDA
Ganirelix AcetateGanirelix AcetateINJECTIONANDA
GlucagonGlucagonKITANDA
ISOPROTERENOL HYDROCHLORIDEIsoproterenol HydrochlorideINJECTION, SOLUTIONANDA
ISOPROTERENOL HYDROCHLORIDEIsoproterenol HydrochlorideINJECTION, SOLUTIONANDA
Medroxyprogesterone AcetateMedroxyprogesterone acetateINJECTION, SUSPENSION, EXTENDED RELEASEANDA
Medroxyprogesterone AcetateMedroxyprogesterone acetateINJECTION, SUSPENSION, EXTENDED RELEASEANDA
NEOSTIGMINE METHYLSULFATEneostigmine methylsulfateINJECTIONANDA
NEOSTIGMINE METHYLSULFATEneostigmine methylsulfateINJECTIONANDA
-Recombinant Human InsulinPOWDERBULK INGREDIENT
TeriparatideTeriparatideINJECTIONANDA
VasopressinVasopressinINJECTIONANDA
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.