Acs

FDA Filings

This page includes the latest FDA filings for Acs. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Acs holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Roerig, Pharmacia & Upjohn Company LLC, ACS DOBFAR SPA
Prescription Medication2023-11-07
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2023-10-27
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2023-10-21
Fresenius Kabi USA, LLC, ACS Dobfar SpA
Prescription Medication2023-10-19
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2023-10-05
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2023-07-21
Roerig, Pharmacia & Upjohn Company LLC, ACS DOBFAR SPA
Prescription Medication2023-03-31
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2023-02-19
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2023-01-25
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A.
Prescription Medication2022-11-11
WG Critical Care, LLC, ACS Dobfar SpA
Prescription Medication2022-11-09
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2022-11-03
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2022-10-27
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2022-10-20
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2022-10-18
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2022-07-17
WG Critical Care, LLC, ACS Dobfar SpA
Prescription Medication2021-10-03
Virbac AH, Inc, GC Hanford Manufacturing Company, ACS DOBFAR SPA
Animal Medication2021-09-23
Virbac AH, Inc, GC Hanford Manufacturing Company, ACS DOBFAR SPA
Animal Medication2021-08-04
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2021-06-19
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2021-06-08
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2021-05-20
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2021-04-24
Roerig, Pharmacia & Upjohn Company LLC, ACS DOBFAR SPA
Prescription Medication2021-03-26
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2021-03-17
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2021-03-16
Fresenius Kabi USA, LLC, ACS DOBFAR SPA, Zambon Switerland Ltd
Prescription Medication2021-03-16
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2021-03-16
WG Critical Care, LLC, ACS Dobfar SpA
Prescription Medication2021-03-11
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switerland Ltd
Prescription Medication2021-03-10
Roerig, Pharmacia & Upjohn Company LLC, ACS DOBFAR SPA
Prescription Medication2020-12-09
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2020-11-25
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2020-11-21
SAMSON MEDICAL TECHNOLOGIES LLC, ACS DOBFAR SPA
Prescription Medication2020-11-20
Samson Medical Technologies, L.L.C., ACS Dobfar S.p.A.
Prescription Medication2020-11-20
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2020-10-31
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A.
Prescription Medication2020-10-29
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2020-10-28
Fresenius Kabi USA, LLC, ACS DOBFAR SPA
Prescription Medication2020-09-26
WG Critical Care, LLC, ACS Dobfar SpA
Prescription Medication2020-09-17
WG Critical Care, LLC, ACS Dobfar SpA
Prescription Medication2020-08-28
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2020-06-24
ACS DOBFAR SPA
2020-06-18
Fresenius Kabi USA, LLC, ACS Dobfar SpA
Prescription Medication2020-06-17
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2020-06-16
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2020-06-05
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2020-03-27
Roerig, Pharmacia & Upjohn Company LLC, ACS DOBFAR SPA
Prescription Medication2020-02-15
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2020-01-23
WG Critical Care, LLC, ACS Dobfar SpA
Prescription Medication2020-01-10
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2020-01-07
SAMSON MEDICAL TECHNOLOGIES LLC, ACS DOBFAR SPA
Prescription Medication2020-01-01
Samson Medical Technologies, L.L.C., ACS Dobfar S.p.A.
Prescription Medication2020-01-01
Fresenius Kabi USA, LLC, ACS DOBFAR SPA, Zambon Switerland Ltd
Prescription Medication2019-12-20
Samson Medical Technologies, L.L.C., ACS Dobfar S.p.A.
Prescription Medication2019-12-09
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A.
Prescription Medication2019-11-23
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switerland Ltd
Prescription Medication2019-11-21
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A.
Prescription Medication2019-10-10
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2019-08-16
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2019-08-02
Fresenius Kabi USA, LLC, ACS Dobfar SpA
Prescription Medication2019-07-23
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2019-07-23
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2019-07-17
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2019-07-17
Fresenius Kabi USA, LLC, ACS DOBFAR SPA, Zambon Switerland Ltd
Prescription Medication2019-06-04
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switerland Ltd
Prescription Medication2019-06-04
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2019-06-04
ACS Dobfar S.p.A
2019-05-22
Fresenius Kabi USA, LLC, ACS DOBFAR SPA, Zambon Switerland Ltd
Prescription Medication2019-04-27
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switerland Ltd
Prescription Medication2019-04-27
Fresenius Kabi USA, LLC, ACS Dobfar S.p.A., Zambon Switzerland Ltd
Prescription Medication2019-04-27
Fresenius Kabi USA, LLC, ACS DOBFAR SPA
Prescription Medication2019-04-18
Roerig, Pharmacia & Upjohn Company LLC, ACS DOBFAR SPA
Prescription Medication2019-03-15
Melinta Therapeutics, Inc., The Medicines Company, ACS DOBFAR S.p.A.
Prescription Medication2019-03-08
Teligent Pharma, Inc., ACSDobfar S.p.A
Prescription Medication2019-02-07
Virbac AH, Inc, GC Hanford Manufacturing Company, ACS DOBFAR SPA
Animal Medication2018-12-12
Samson Medical Technologies, L.L.C., ACS Dobfar S.p.A.
Prescription Medication2018-11-10
Insmed Incorporated, ACS Dobfar S.p.A., Ajinomoto Althea, Inc., Therapure Biopharma, Inc., Covance Laboratories, Wickham Laboratories Ltd, Alcami Carolinas Corporation, Sharp Corporation
Prescription Medication2018-10-16
SAMSON MEDICAL TECHNOLOGIES LLC, ACS DOBFAR SPA
Prescription Medication2016-03-01
ACS Dobfar SPA
2015-09-14
ACS Dobfar Spa
2013-06-13
ACS Dobfar SpA
2012-08-30
ACS Dobfar SPA
2010-04-19
ACS Dobfar S.p.A
2010-03-02
ACS Dobfar S.p.A
2010-02-22
ACS Dobfar S.p.A
2009-12-10
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar S.p.A
2009-12-09
ACS Dobfar SpA
2009-12-09
ACS Dobfar SpA
2009-12-09
ACS Dobfar S.p.A.
2009-12-09
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR SPA
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00
ACS DOBFAR
0000-00-00 00:00:00

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201808013854Singapore,Singapore -> New York/Newark Area, Newark, New JerseyLACQUER& CERAMIC HANDICRAFT PRODUCTS, LACQUER PRODUCTS HS CODE 44209000 CERAMIC HANDICRAFT PRODUCTS HS CODE 69141000235 CTN
201806129050Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyVASE, TRAY, BOX, LACQUER PRODUCTS (VASE, TRAY, BOX, PHOTO FRAME,COCONUT BOWL) HS CODE 44209000 ; 46021100 AMS HBL ACS1805001 SCAC CODE ACDF ## FAX ; 201 226 0870280 CTN
2018052212033Singapore,Singapore -> New York/Newark Area, Newark, New JerseyBAMBOO AND LACQUER WARE VASE BAMBOO AND LACQUER WARE VASE HS CODE 46021100 AMS HBL ACS1804003 SCAC CODE ACDF312 CTN
201804025691FOS Sur Mer,France -> Long Beach, CaliforniaSCRAPER PU CATERPILLAR HS CODE : 843149809 PKG
2018021940170Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 44 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 135 CARTONS LOADED ON 14 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 2.1, 3, 4.1 UN-NUMBERS 1,170,126,619,933,170 LIST FOR E.L. REF 10016944197039 PCS
2018021940170Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 45 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 119 CARTONS LOADED ON 20 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 2.1, 3, 4.1 UN-NUMBERS 11,701,266,195,019,900,000 LIST FOR E.L. REF 10016932717039 PCS
2018021940170Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 38 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 150 CARTONS LOADED ON 13 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 126,312, 661,993 LIST FOR E.L. REF 10016952917039 PCS
2018021940170Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 42 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 1273 CARTONS LOADED ON 29 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 12,661,993 LIST FOR E.L. REF 10016952157039 PCS
2018021643283Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 44 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 135 CARTONS LOADED ON 14 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 2.1, 3, 4.1 UN-NUMBERS 1,170,126,619,933,170 LIST FOR E.L. REF 10016944197039 PCS
2018021643283Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 45 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 119 CARTONS LOADED ON 20 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 2.1, 3, 4.1 UN-NUMBERS 11,701,266,195,019,900,000 LIST FOR E.L. REF 10016932717039 PCS
2018021643283Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 38 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 150 CARTONS LOADED ON 13 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 126,312, 661,993 LIST FOR E.L. REF 10016952917039 PCS
2018021643283Anvers,Belgium -> New York/Newark Area, Newark, New JerseyLOADED ON 42 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 1273 CARTONS LOADED ON 29 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 12,661,993 LIST FOR E.L. REF 10016952157039 PCS
2018020819254Genova,Italy -> Miami, FloridaCONVEYING SYSTEMS6 PKG
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 42 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 624 CARTONS LOADED ON 30 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 117,012,661,993 LIST FOR E.L. REF 100165588717160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 28 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 100 CARTONS LOADED ON 7 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 117,012,661,993 LIST FOR E.L. REF 1001656083 GW 6,921.40 KGS17160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 44 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 811 CARTONS LOADED ON 28 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 117,012,661,993 LIST FOR E.L. REF 100165598817160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 42 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 480 CARTONS LOADED ON 17 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 11,701,993 LIST FOR E.L. REF 100165699717160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 43 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 333 CARTONS LOADED ON 14 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 126,312,661,993 LIST FOR E.L. REF 100165742417160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 41 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 199 CARTONS LOADED ON 9 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 2.1, 3, 4.1 UN-NUMBERS 1,263,126,619,503,17017160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 23 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 49 CARTONS LOADED ON 1 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 1, 993 LIST FOR E.L. REF 100164670617160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New Jersey2168 CARTONS LOADED ON 45 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 283 CARTONS LOADED ON 6 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3, 4. UN-NUMBERS 11,703,175 LIST FOR E.L. REF 100165707817160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 28 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 100 CARTONS LOADED ON 7 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 117,012,661,993 LIST FOR E.L. REF 1001656083 GW 6,921.40 KGS17160 PCS
2018013059305Anvers,Belgium -> New York/Newark Area, Newark, New JerseyCARTONS LOADED ON 34 PALLETS S.T.C. COSMETIC PRODUCTS OF WHICH 562 CARTONS LOADED ON 31 PALLETS WITH DANGEROUS GOODS IN LIMITED QUANTITIES OF CLASS 3 UN-NUMBERS 12,661,993 LIST FOR E.L. REF 100165711317160 PCS

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