This page includes the latest FDA filings for American Regent Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2410375 |
| FEI Number | 2410375 |
| Name | AMERICAN REGENT, INC. |
| Owner & Operator | AMERICAN REGENT, INC. |
| Contact Address | 5 RAMSEY ROAD Shirley NY 11967 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 5 Ramsey Road Shirley, NY 11967 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
| American Regent, Inc. | Prescription Medication | 2024-12-19 |
| Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2024-11-21 |
| Civica, Inc., American Regent, Inc. | Prescription Medication | 2024-11-09 |
| American Regent, Inc. | Prescription Medication | 2024-11-02 |
| American Regent, Inc. | Prescription Medication | 2024-10-30 |
| American Regent, Inc. | Prescription Medication | 2024-10-10 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2024-10-09 |
| American Regent, Inc. | Animal Medication | 2024-10-09 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2024-10-09 |
| American Regent, Inc. | Animal Medication | 2024-10-09 |
| American Regent, Inc. | Prescription Medication | 2024-09-13 |
| American Regent, Inc. | Prescription Medication | 2024-09-11 |
| American Regent, Inc. | Prescription Medication | 2024-09-04 |
| American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2024-09-04 |
| American Regent, Inc. | Prescription Medication | 2024-08-24 |
| American Regent, Inc. | Prescription Medication | 2024-08-24 |
| American Regent, Inc. | Prescription Medication | 2024-07-12 |
| American Regent, Inc. | Prescription Medication | 2024-07-12 |
| American Regent, Inc. | Prescription Medication | 2024-06-25 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2024-06-15 |
| American Regent, Inc. | Prescription Medication | 2024-06-07 |
| American Regent, Inc., Cenexi | Prescription Medication | 2024-05-17 |
| American Regent, Inc. | Prescription Medication | 2024-05-16 |
| Civica, Inc., American Regent, Inc. | Prescription Medication | 2024-04-29 |
| American Regent, Inc., PharmaForce, Inc. | Prescription Medication | 2024-04-20 |
| American Regent, Inc. | Prescription Medication | 2024-03-28 |
| American Regent, Inc. | Prescription Medication | 2024-03-15 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2024-02-15 |
| American Regent, Inc. | Prescription Medication | 2024-02-08 |
| American Regent, Inc. | Prescription Medication | 2024-02-01 |
| American Regent, Inc. | Prescription Medication | 2024-01-30 |
| American Regent, Inc. | Prescription Medication | 2024-01-23 |
| American Regent, Inc. | Prescription Medication | 2024-01-23 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2024-01-13 |
| American Regent, Inc. | Prescription Medication | 2024-01-12 |
| American Regent, Inc. | Prescription Medication | 2023-11-18 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2023-11-15 |
| Padagis US LLC | Prescription Medication | 2023-11-14 |
| XGen Pharmaceuticals DJB, Inc. | Prescription Medication | 2023-11-08 |
| American Regent, Inc. | Prescription Medication | 2023-11-01 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2023-10-27 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2023-10-18 |
| American Regent, Inc. | Prescription Medication | 2023-10-13 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2023-10-11 |
| American Regent, Inc. | Animal Medication | 2023-10-11 |
| American Regent, Inc. | Animal Medication | 2023-10-11 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2023-10-10 |
| Padagis US LLC | Prescription Medication | 2023-09-02 |
| American Regent, Inc., Luitpold Pharmaceuticals, Inc. | Prescription Medication | 2023-08-25 |
| American Regent, Inc., Cenexi | Prescription Medication | 2023-08-17 |
| American Regent, Inc. | Prescription Medication | 2023-06-21 |
| American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2023-06-08 |
| BluePoint Laboratories, American Regent, Inc. | Prescription Medication | 2023-05-06 |
| American Regent, Inc. | Prescription Medication | 2023-05-05 |
| American Regent, Inc. | Prescription Medication | 2023-04-01 |
| American Regent, Inc. | Prescription Medication | 2023-03-21 |
| American Regent, Inc. | Prescription Medication | 2023-03-10 |
| Civica, Inc., American Regent, Inc. | Prescription Medication | 2023-03-02 |
| Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2023-01-07 |
| American Regent, Inc. | Prescription Medication | 2023-01-07 |
| American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2023-01-07 |
| American Regent, Inc., Cenexi | Prescription Medication | 2023-01-01 |
| American Regent, Inc., Luitpold Pharmaceuticals, Inc. | Prescription Medication | 2022-12-28 |
| XGen Pharmaceuticals DJB, Inc. | Prescription Medication | 2022-12-17 |
| American Regent, Inc. | Prescription Medication | 2022-12-08 |
| American Regent, Inc. | Prescription Medication | 2022-12-05 |
| American Regent, Inc. | Prescription Medication | 2022-12-04 |
| American Regent, Inc. | Prescription Medication | 2022-12-03 |
| American Regent, Inc. | Prescription Medication | 2022-12-03 |
| American Regent, Inc. | Prescription Medication | 2022-12-03 |
| American Regent, Inc. | Prescription Medication | 2022-12-03 |
| American Regent, Inc. | Prescription Medication | 2022-12-02 |
| American Regent, Inc., Luitpold Pharmaceuticals, Inc. | Prescription Medication | 2022-12-02 |
| American Regent, Inc. | Prescription Medication | 2022-12-02 |
| American Regent, Inc., Luitpold Pharmaceuticals, Inc. | Prescription Medication | 2022-12-02 |
| American Regent, Inc. | Prescription Medication | 2022-12-02 |
| American Regent, Inc., PharmaForce, Inc. | Prescription Medication | 2022-11-23 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2022-10-18 |
| American Regent, Inc. | Animal Medication | 2022-10-18 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2022-10-18 |
| American Regent, Inc. | Animal Medication | 2022-10-18 |
| American Regent, Inc., Daiichi Sankyo Altrich Sari | Animal Medication | 2022-10-18 |
| American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2022-09-24 |
| American Regent, Inc. | Prescription Medication | 2022-09-11 |
| American Regent, Inc. | Prescription Medication | 2022-09-08 |
| American Regent, Inc. | Prescription Medication | 2022-09-01 |
| American Regent, Inc. | Prescription Medication | 2022-08-05 |
| Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2022-07-26 |
| American Regent, Inc. | Prescription Medication | 2022-07-26 |
| American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2022-07-26 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2022-07-06 |
| BluePoint Laboratories, American Regent, Inc. | Prescription Medication | 2022-07-01 |
| American Regent, Inc. | Injectafer | 2022-06-01 |
| American Regent, Inc., Vifor (International) Inc. | Prescription Medication | 2022-06-01 |
| American Regent, Inc. | Prescription Medication | 2022-05-26 |
| American Regent, Inc., Provepharm SAS, Cenexi, CENEXI HSC | Prescription Medication | 2022-05-13 |
| American Regent, Inc. | Prescription Medication | 2022-04-30 |
| American Regent, Inc. | Prescription Medication | 2022-04-22 |
| Amneal Pharmaceuticals of NY LLC, American Regent, Inc. | Prescription Medication | 2022-04-15 |
| Amneal Pharmaceuticals of NY LLC, American Regent, Inc. | Prescription Medication | 2022-04-12 |
| American Regent, Inc. | Prescription Medication | 2022-03-30 |
| American Regent, Inc. | Injectafer | 2021-06-01 |
AMERICAN REGENT INC | 2020-07-07 19:08:18 | |
| American Regent, Inc. | Nicardipine Hydrochloride | 2020-05-08 |
| American Regent, Inc. | PROVAYBLUE | 2020-04-08 |
| American Regent, Inc. | PROVAYBLUE | 2020-04-08 |
| American Regent, Inc. | ESTRADIOL VALERATE | 2020-03-01 |
| American Regent, Inc. | ESTRADIOL VALERATE | 2020-03-01 |
| American Regent, Inc. | Betamethasone Sodium Phosphate And Betamethasone Acetate | 2019-11-01 |
| American Regent, Inc. | Betamethasone Sodium Phosphate And Betamethasone Acetate | 2019-11-01 |
| American Regent, Inc. | Selenious Acid | 2019-07-01 |
| American Regent, Inc. | Hydroxyprogesterone Caproate | 2019-03-01 |
| American Regent, Inc. | Aminocaproic Acid | 2019-02-01 |
| American Regent, Inc. | Fomepizole | 2018-07-16 |
| American Regent, Inc. | Hydroxyprogesterone Caproate | 2018-06-28 |
| American Regent, Inc. | Neostigmine Methylsulfate | 2018-05-14 |
| American Regent, Inc. | Neostigmine Methylsulfate | 2018-05-14 |
| American Regent, Inc. | Calcium Chloride | 2018-02-06 |
| American Regent, Inc. | Methocarbamol | 2018-01-15 |
| American Regent, Inc. | Dicyclomine Hydrochloride | 2017-09-01 |
| American Regent, Inc. | Calcium Chloride | 2017-07-05 |
| American Regent, Inc. | 2017-04-01 | |
| American Regent, Inc. | PROVAYBLUE | 2016-04-08 |
| American Regent, Inc. | PROVAYBLUE | 2016-04-08 |
| American Regent, Inc. | Chlorothiazide Sodium | 2015-04-01 |
| American Regent, Inc. | Injectafer | 2013-08-12 |
| American Regent, Inc. | Olanzapine | 2012-06-27 |
| American Regent, Inc. | Tranexamic Acid | 2011-11-15 |
| American Regent, Inc. | Latanoprost | 2011-08-02 |
| American Regent, Inc. | Benztropine Mesylate | 2011-02-04 |
| American Regent, Inc. | Venofer | 2011-01-27 |
| American Regent, Inc. | Progesterone | 2010-09-29 |
| American Regent, Inc. | Buprenorphine Hydrochloride | 2010-08-13 |
| American Regent, Inc. | Ofloxacin | 2010-07-01 |
| American Regent, Inc. | Methylergonovine Maleate | 2010-06-21 |
| American Regent, Inc. | Torsemide | 2010-05-26 |
| American Regent, Inc. | Torsemide | 2010-05-21 |
| American Regent, Inc. | Betamethasone Sodium Phosphate And Betamethasone Acetate | 2010-04-28 |
AMERICAN REGENT, INC. | GEM 21S | 2009-06-05 |
AMERICAN REGENT, INC. | GEM 21S | 2009-06-05 |
| American Regent, Inc. | Ketorolac Tromethamine | 2008-05-30 |
| American Regent, Inc. | Ketorolac Tromethamine | 2008-05-30 |
| American Regent, Inc. | Ketorolac Tromethamine | 2008-05-30 |
| American Regent, Inc. | Caffeine Citrate | 2007-09-10 |
| American Regent, Inc. | Venofer | 2007-06-12 |
| American Regent, Inc. | Cyanocobalamin | 2003-05-29 |
| American Regent, Inc. | Nitroglycerin | 2003-03-04 |
| American Regent, Inc. | Levocarnitine | 2001-10-08 |
| American Regent, Inc. | Venofer | 2000-11-10 |
| American Regent, Inc. | Nandrolone Decanoate | 2000-01-01 |
| American Regent, Inc. | Sterile Water | 1999-01-25 |
| American Regent, Inc. | Hydralazine Hydrochloride | 1997-06-30 |
| American Regent, Inc. | Cyanocobalamin | 1996-11-07 |
| American Regent, Inc. | Sterile Water | 1996-09-03 |
| American Regent, Inc. | Acetylcysteine | 1995-10-01 |
| American Regent, Inc. | Acetylcysteine | 1995-10-01 |
| American Regent, Inc. | Acetylcysteine | 1995-10-01 |
| American Regent, Inc. | Acetylcysteine | 1995-10-01 |
| American Regent, Inc. | Acetylcysteine | 1995-10-01 |
| American Regent, Inc. | Papaverine Hydrochloride | 1995-09-01 |
| American Regent, Inc. | Epinephrine | 1994-03-01 |
| American Regent, Inc. | Trace Elements 4 | 1994-02-24 |
| American Regent, Inc. | Multitrace-5 | 1994-02-17 |
| American Regent, Inc. | Multitrace-4 | 1994-02-17 |
| American Regent, Inc. | Multitrace-5 | 1993-12-17 |
| American Regent, Inc. | Multitrace -4 Pediatric | 1993-12-09 |
| American Regent, Inc. | Multitrace -4 | 1993-12-07 |
| American Regent, Inc. | Multitrace -4 | 1993-11-29 |
| American Regent, Inc. | Multitrace-5 | 1993-09-14 |
| American Regent, Inc. | Caffeine And Sodium Benzoate | 1993-02-01 |
| American Regent, Inc. | Calcium Gluconate | 1992-12-01 |
| American Regent, Inc. | Atropine Sulfate | 1992-12-01 |
| American Regent, Inc. | Atropine Sulfate | 1992-11-01 |
| American Regent, Inc. | Droperidol | 1990-09-30 |
| American Regent, Inc. | Aminocaproic Acid | 1990-09-30 |
| American Regent, Inc. | Dehydrated Alcohol | 1990-09-30 |
| American Regent, Inc. | Zinc Sulfate | 1990-09-30 |
| American Regent, Inc. | Selenium | 1990-09-30 |
| American Regent, Inc. | Manganese Sulfate | 1990-09-30 |
| American Regent, Inc. | Multitrace-4 Neonatal | 1990-09-30 |
| American Regent, Inc. | Zinc Sulfate | 1990-09-30 |
| American Regent, Inc. | Hydroxyzine Hydrochloride | 1990-09-30 |
| American Regent, Inc. | Hydroxyzine Hydrochloride | 1990-09-30 |
| American Regent, Inc. | Sodum Acetate | 1990-09-30 |
| American Regent, Inc. | Glycopyrrolate | 1990-09-30 |
| American Regent, Inc. | Glycopyrrolate | 1990-09-30 |
| American Regent, Inc. | Glycopyrrolate | 1990-09-30 |
| American Regent, Inc. | Glycopyrrolate | 1990-09-30 |
| American Regent, Inc. | Hydroxyzine Hydrochloride | 1990-09-30 |
| American Regent, Inc. | Calcium Gluconate | 1990-09-30 |
| American Regent, Inc. | Sterile Water | 1990-09-30 |
| American Regent, Inc. | Sodium Chloride | 1990-09-30 |
| American Regent, Inc. | Indigo Carmine | 1990-09-30 |
| American Regent, Inc. | Cyanocobalamin | 1990-09-30 |
American Regent, Inc. | 0000-00-00 00:00:00 |
| NCAGE Code | 7PXG8 | AMERICAN REGENT, INC. |
| CAGE Code | 7PXG8 | AMERICAN REGENT, INC. |
| S.A.M. Registration | 7PXG8 [622781813] | AMERICAN REGENT, INC. |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 202009299667 | Anvers,Belgium -> New York, New York | PHARMACEUTICALS VENOFER CONCENTRATE USAHS-COD E: 3003.90 | 32 PKG |
| 2020092859835 | Anvers,Belgium -> New York, New York | LOADED ON 6 PALLETS PHARMACEUTICALS | 36 DRM |
| 2020092668210 | Anvers,Belgium -> New York, New York | LOADED ON 6 PALLETS PHARMACEUTICALS | 36 DRM |
| 2020091449598 | Anvers,Belgium -> New York, New York | PHARMACEUTICALS VENOFER CONCENTRATE USAHS-COD E: 3003.90 | 32 PKG |
| 2020091236809 | Anvers,Belgium -> New York, New York | PHARMACEUTICALS VENOFER CONCENTRATE USAHS-COD E: 3003.90 | 32 PKG |
| 2020090259922 | Anvers,Belgium -> New York, New York | PHARMACEUTICALS VENOFER CONCENTRATE USAHS-COD E: 3003.90 | 32 PKG |
| 2020071440439 | Anvers,Belgium -> New York, New York | PHARMACEUTICAL PRODUCTS HS-CODE:30 | 580 BOX |
| 2020071154448 | Anvers,Belgium -> New York, New York | PHARMACEUTICAL PRODUCTS HS-CODE:30 | 580 BOX |