Register entry

Amneal Pharmaceuticals of New York, LLC

Data as of · How to read this entry

Registered sites
14
Active NDC listings
227
Labeller names
2
Live patents
0
Countries
2
Base
India
Authorisation

Registered operations

Analytical testing12Labelling10Finished drug manufacture12Packaging12Relabelling1Repackaging3sterilize4
Sites

Registered establishments

14
EstablishmentAddressRegistered forFEI / DUNS
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCSurvey No.634, 637 To 641, Near Hotel Kankavati Sarkhej-Bavla Highway, Village Rajoda, Tal Bavla, Ahmedabad, Gujarat 382220, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3008223599915076126
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCPlot No. 15, PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal. Sanand, Ahmedabad, GJ 382213, India (IND)Analytical testing, Finished drug manufacture, Packaging, sterilize3010254278860156658
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCPlot No 16 & 17, PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal.: Sanand, Ahmedabad, GJ 382213, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3010661577650762060
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCSurvey No. 168/1/1, Pipan, Sanand, Ahmedabad, Gujarat 382110, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging, sterilize3017573557675474666
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCPlot No. 15,16,17 PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal. Sanand, Ahmedabad, Gujarat 382213, India (IND)Labelling, Finished drug manufacture, Packaging3029456823959962800
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLC2nd Floor, W-1, Ambli Road, New York Timber Street, Opp PSP House, S.G. Highway, Ahmedabad, Gujarat 380053, India (IND)Analytical testing3030461061644903923
Amneal Oncology Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCPlot No. S-3, S-4, S-5A, TSIIC-SEZ Village-Polepally Mandal-Jadcherla MAHABOOBNAGAR, Mahaboobnagar, TG 509301, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3005903939860037948
Amneal Pharmaceuticals Private LimitedRegistrant: Amneal Pharmaceuticals of New York, LLCSurvey No. 506, Palli Near Sachana Kalyanpura Road, Mehsana, GJ 382165, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3018907202854377396
Amneal Pharmaceuticals, LLCRegistrant: Amneal Pharmaceuticals of New York, LLC131 Chambers Brook Rd Bldg A, Branchburg, New Jersey (NJ) 08876-3587, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging3004488497963900878
Amneal Complex Products Research LLCRegistrant: Amneal Pharmaceuticals of New York, LLC995 US Highway 202/206, Bridgewater, New Jersey (NJ) 08807-1244, United States (USA)Analytical testing, Finished drug manufacture3010529997117580013
Amneal Pharmaceuticals of New York, LLC50 Horseblock Rd, Brookhaven, New York (NY) 11719-9509, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging3005263655123797875
Amneal Pharmaceuticals, LLCRegistrant: Amneal Pharmaceuticals of New York, LLC1 Murray Rd, East Hanover, New Jersey (NJ) 07936-2205, United States (USA)Packaging3009268752969951594
Amneal Pharmaceuticals of New York, LLC75 Adams Ave, Hauppauge, New York (NY) 11788-3605, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging2434153831227801
Amneal Pharmaceuticals, LLCRegistrant: Amneal Pharmaceuticals of New York, LLC1045 Centennial Ave Bldg C, Piscataway, New Jersey (NJ) 08854-4124, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging3008861605081303847
Catalogue

Drug listings by form and route

227

227 active NDC listings: 218 human prescription drug, 9 human otc drug. By marketing category: ANDA 216, NDA AUTHORIZED GENERIC 8, UNAPPROVED DRUG OTHER 2, NDA 1.

Dosage formNDCs
tablet105
capsule, extended release30
capsule28
tablet, film coated20
tablet, film coated, extended release10
tablet, orally disintegrating8
tablet, coated7
suspension4
capsule, delayed release3
solution3
injection2
powder, for suspension2
for suspension1
gel1
insert1
RouteNDCs
oral217
respiratory (inhalation)5
subcutaneous2
auricular (otic)1
topical1
vaginal1
Labeller name on the listingNDCs
amneal pharmaceuticals of new york llc226
amneal pharmaceuticals of new york, llc1
Catalogue

Marketed products

227

Showing 150 of 227.

BrandGeneric nameForm / routeNDC
Acebutolol HydrochlorideAcebutolol Hydrochloridecapsule, oral53746-669ANDA
Acebutolol HydrochlorideAcebutolol Hydrochloridecapsule, oral53746-670ANDA
AcitretinAcitretincapsule, oral0115-1750ANDA
AcitretinAcitretincapsule, oral0115-1751ANDA
AcitretinAcitretincapsule, oral0115-1752ANDA
AcitretinAcitretincapsule, oral0115-1753ANDA
Albendazolealbendazoletablet, film coated, oral0115-1701NDA
Alendronate SodiumAlendronate Sodiumtablet, oral0115-1676ANDA
Alendronate SodiumAlendronate Sodiumtablet, oral0115-1678ANDA
Alendronate SodiumAlendronate Sodiumtablet, oral0115-1679ANDA
Alendronate SodiumAlendronate Sodiumtablet, oral0115-1680ANDA
Alendronate SodiumAlendronate Sodiumtablet, oral0115-1681ANDA
Alosetron HydrochlorideAlosetron Hydrochloridetablet, film coated, oral53746-248ANDA
Alosetron HydrochlorideAlosetron Hydrochloridetablet, film coated, oral53746-249ANDA
ApixabanApixabantablet, film coated, oral0115-1721ANDA
ApixabanApixabantablet, film coated, oral0115-1722ANDA
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATEBUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATEcapsule, oral69238-1993ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral53746-751ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral53746-752ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral53746-753ANDA
Benazepril HydrochlorideBenazepril Hydrochloridetablet, oral53746-754ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral53746-571ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral53746-572ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral53746-573ANDA
Bethanechol ChlorideBethanechol Chloridetablet, oral53746-574ANDA
BudesonideBudesonidecapsule, delayed release, oral53746-778ANDA
Budesonide InhalationBudesonidesuspension, respiratory (inhalation)0115-1687ANDA
Budesonide InhalationBudesonidesuspension, respiratory (inhalation)0115-1689ANDA
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEtablet, film coated, extended release, oral0115-5445ANDA
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEtablet, film coated, extended release, oral0115-6811ANDA
COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEtablet, film coated, oral0115-5211ANDA
COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEsuspension, oral0115-5212ANDA
COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEsuspension, oral0115-5213ANDA
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEtablet, film coated, oral53746-540ANDA
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEtablet, film coated, oral53746-541ANDA
Calcium AcetateCalcium Acetatecapsule, oral53746-590ANDA
Carvedilol PhosphateCARVEDILOL PHOSPHATEcapsule, extended release, oral0115-1248ANDA
Carvedilol PhosphateCARVEDILOL PHOSPHATEcapsule, extended release, oral0115-1249ANDA
Carvedilol PhosphateCARVEDILOL PHOSPHATEcapsule, extended release, oral0115-1250ANDA
Carvedilol PhosphateCARVEDILOL PHOSPHATEcapsule, extended release, oral0115-1251ANDA
Chloroquine PhosphateCHLOROQUINE PHOSPHATEtablet, oral0115-2790ANDA
Chloroquine PhosphateCHLOROQUINE PHOSPHATEtablet, oral0115-7010ANDA
Ciprofloxacin and DexamethasoneCiprofloxacin and Dexamethasonesuspension/ drops, auricular (otic)53746-831ANDA
Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloridepowder, for solution, oral53746-468ANDA
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEtablet, film coated, oral0115-1320ANDA
Colesevelam hydrochlorideColesevelam hydrochloridefor suspension, oral0115-1864ANDA
Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloridecapsule, extended release, oral0115-1436NDA AUTHORIZED GENERIC
Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloridecapsule, extended release, oral0115-1437NDA AUTHORIZED GENERIC
Cyproheptadine HydrochlorideCyproheptadine Hydrochloridetablet, oral0115-1757ANDA
Dantrolene SodiumDantrolene Sodiumcapsule, oral0115-4411ANDA
Dantrolene SodiumDantrolene Sodiumcapsule, oral0115-4422ANDA
Dantrolene SodiumDantrolene Sodiumcapsule, oral0115-4433ANDA
Demeclocycline HydrochlorideDemeclocyclinetablet, oral53746-554ANDA
Demeclocycline HydrochlorideDemeclocyclinetablet, oral53746-555ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-1709ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-1710ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-9918ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-9919ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-9920ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-9921ANDA
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloridecapsule, extended release, oral0115-9922ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatecapsule, oral0115-1486ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatecapsule, oral0115-1487ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatecapsule, oral0115-1488ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatecapsule, oral0115-1489ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatecapsule, oral0115-1490ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatecapsule, oral0115-1491ANDA
Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfatecapsule, extended release, oral0115-9927NDA AUTHORIZED GENERIC
Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfatecapsule, extended release, oral0115-9928NDA AUTHORIZED GENERIC
Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfatecapsule, extended release, oral0115-9929NDA AUTHORIZED GENERIC
Diclofenac SodiumDiclofenac Sodiumgel, topical0115-1483ANDA
DigoxinDIGOXINtablet, oral0115-9811ANDA
DigoxinDIGOXINtablet, oral0115-9822ANDA
DipyridamoleDIPYRIDAMOLEtablet, oral0115-1070ANDA
DipyridamoleDIPYRIDAMOLEtablet, oral0115-1071ANDA
DipyridamoleDIPYRIDAMOLEtablet, oral0115-1072ANDA
Escitalopram OxalateEscitalopram Oxalatetablet, film coated, oral53746-019ANDA
Escitalopram OxalateEscitalopram Oxalatetablet, film coated, oral53746-020ANDA
Escitalopram OxalateEscitalopram Oxalatetablet, film coated, oral53746-021ANDA
Esterified Estrogens and MethyltestosteroneEsterified Estrogens and Methyltestosteronetablet, oral53746-077UNAPPROVED DRUG OTHER
Esterified Estrogens and MethyltestosteroneEsterified Estrogens and Methyltestosteronetablet, oral53746-078UNAPPROVED DRUG OTHER
EstradiolEstradiolinsert, vaginal53746-226ANDA
FENOFIBRATEFENOFIBRATEtablet, oral0115-5511ANDA
FENOFIBRATEFENOFIBRATEtablet, oral0115-5522ANDA
FelbamateFelbamatetablet, oral53746-734ANDA
FelbamateFelbamatetablet, oral53746-735ANDA
Fenofibric AcidFENOFIBRIC ACIDcapsule, delayed release, oral0115-1324ANDA
Fenofibric AcidFENOFIBRIC ACIDcapsule, delayed release, oral0115-1325ANDA
Flecainide AcetateFlecainide Acetatetablet, oral53746-641ANDA
Flecainide AcetateFlecainide Acetatetablet, oral53746-642ANDA
Flecainide AcetateFlecainide Acetatetablet, oral53746-643ANDA
Fludrocortisone AcetateFLUDROCORTISONE ACETATEtablet, oral0115-7033ANDA
Folic AcidFolic Acidtablet, oral53746-361ANDA
GabapentinGabapentincapsule, oral53746-101ANDA
GabapentinGabapentincapsule, oral53746-102ANDA
GabapentinGabapentincapsule, oral53746-103ANDA
Guanfacine HydrochlorideGuanfacinetablet, oral53746-711ANDA
Guanfacine HydrochlorideGuanfacinetablet, oral53746-713ANDA
HYDROCORTISONEhydrocortisonetablet, oral0115-1696ANDA
HYDROCORTISONEhydrocortisonetablet, oral0115-1697ANDA
HYDROCORTISONEhydrocortisonetablet, oral0115-1700ANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophentablet, oral53746-109ANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophentablet, oral53746-110ANDA
Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofentablet, oral53746-116ANDA
Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofentablet, oral53746-117ANDA
Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofentablet, oral53746-145ANDA
Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofentablet, oral53746-146ANDA
Hydroxyzine PamoateHydroxyzine Pamoatecapsule, oral0115-1803ANDA
Hydroxyzine PamoateHydroxyzine Pamoatecapsule, oral0115-1804ANDA
IbuprofenIbuprofentablet, oral53746-131ANDA
IbuprofenIbuprofentablet, oral53746-132ANDA
IbuprofenIbuprofentablet, oral53746-137ANDA
IbuprofenIbuprofentablet, oral53746-458ANDA
IbuprofenIbuprofentablet, oral53746-460ANDA
IbuprofenIbuprofentablet, oral53746-462ANDA
IbuprofenIbuprofentablet, oral53746-464ANDA
IbuprofenIbuprofentablet, oral53746-465ANDA
IbuprofenIbuprofentablet, oral53746-466ANDA
Ibuprofen (NSAID) Pain Releiver/ Fever ReducerIbuprofentablet, oral53746-142ANDA
Ibuprofen (NSAID) Pain Releiver/ Fever ReducerIbuprofentablet, oral53746-144ANDA
Ibuprofen Pain Releiver/ Fever ReducerIbuprofentablet, oral53746-140ANDA
Ibuprofen Pain Releiver/ Fever ReducerIbuprofentablet, oral53746-143ANDA
LacosamideLacosamidetablet, oral53746-923ANDA
LacosamideLacosamidetablet, oral53746-924ANDA
LacosamideLacosamidetablet, oral53746-925ANDA
LacosamideLacosamidetablet, oral53746-926ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-1526ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-1527ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-1528ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-1529ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-9939ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-9940ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-9941ANDA
LamotrigineLAMOTRIGINEtablet, orally disintegrating, oral0115-9942ANDA
LevalbuterolLevalbuterol Hydrochloridesolution, respiratory (inhalation)0115-9930ANDA
LevalbuterolLevalbuterol Hydrochloridesolution, respiratory (inhalation)0115-9931ANDA
LevalbuterolLevalbuterol Hydrochloridesolution, respiratory (inhalation)0115-9932ANDA
Lurasidone HydrochlorideLurasidone Hydrochloridetablet, coated, oral53746-082ANDA
Lurasidone HydrochlorideLurasidone Hydrochloridetablet, coated, oral53746-879ANDA
Lurasidone HydrochlorideLurasidone Hydrochloridetablet, coated, oral53746-880ANDA
Lurasidone HydrochlorideLurasidone Hydrochloridetablet, coated, oral53746-881ANDA
Lurasidone HydrochlorideLurasidone Hydrochloridetablet, coated, oral53746-882ANDA
METHITESTMETHYLTESTOSTERONEtablet, oral0115-7037ANDA
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEtablet, oral0115-1800ANDA
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEtablet, oral0115-1801ANDA
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEtablet, oral0115-1802ANDA
Meclizine HydrochlorideMeclizine Hydrochloridetablet, oral53746-441ANDA
Meclizine HydrochlorideMeclizine Hydrochloridetablet, oral53746-442ANDA
Memantine hydrochlorideMemantinetablet, film coated, oral53746-169ANDA
Memantine hydrochlorideMemantinetablet, film coated, oral53746-173ANDA
Neighbours

Registered in the same town

12
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Enquiry

Common questions

Is Amneal Pharmaceuticals of New York, LLC FDA approved?
Amneal Pharmaceuticals of New York, LLC holds 14 FDA-registered establishments across 2 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 Amneal Pharmaceuticals of New York, LLC's drugs manufactured?
At registered sites in India, the United States. The FDA register lists Ahmedabad; Mahaboobnagar; Mehsana; Branchburg, NJ; Bridgewater, NJ; Brookhaven, NY, and 3 more. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.
What drugs does Amneal Pharmaceuticals of New York, LLC make?
227 products are listed under Amneal Pharmaceuticals of New York, LLC in the openFDA NDC Directory, most often as tablet; capsule, extended release; capsule. 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.