Amneal Pharmaceuticals

FDA Filings

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

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Amneal Pharmaceuticals of New York LLC
Otc Medication2024-01-01
Amneal Pharmaceuticals LLC
Prescription Medication2023-12-20
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals, LLC
Prescription Medication2023-12-19
Amneal Pharmaceuticals, LLC, Identi Pharmaceuticals LLC, Amneal Pharmaceuticals
Prescription Medication2023-12-19
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC
Otc Medication2023-08-18
Amneal Pharmaceuticals
Otc Medication2023-08-18
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals, LLC
Prescription Medication2022-12-26
Amneal Pharmaceuticals LLC
Prescription Medication2022-12-26
Amneal Pharmaceuticals, LLC, Identi Pharmaceuticals LLC, Amneal Pharmaceuticals
Prescription Medication2022-12-26
Amneal Pharmaceuticals of New York LLC
Otc Medication2022-11-02
Amneal Pharmaceuticals, AstraZeneca PLC
Prescription Medication2022-10-27
Amneal Pharmaceuticals
Prescription Medication2022-10-21
Amneal Pharmaceuticals
Prescription Medication2022-10-20
Amneal Pharmaceuticals
Zolmitriptan2021-01-18
Amneal Pharmaceuticals
Zolmitriptan2021-01-18
Amneal Pharmaceuticals
Prescription Medication2021-01-18
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals, LLC
Prescription Medication2020-12-01
Amneal Pharmaceuticals LLC
Prescription Medication2020-12-01
Amneal Pharmaceuticals, LLC, Identi Pharmaceuticals LLC, Amneal Pharmaceuticals
Prescription Medication2020-12-01
Amneal Pharmaceuticals of New York LLC
Otc Medication2020-11-24
Amneal Pharmaceuticals
Prescription Medication2020-02-29
Amneal Pharmaceuticals, AstraZeneca PLC
Prescription Medication2020-02-29
Amneal Pharmaceuticals
Prescription Medication2019-06-01
Amneal Pharmaceuticals, AstraZeneca PLC
Prescription Medication2019-06-01
BluePoint Laboratories, Amneal Pharmaceuticals, Amneal Pharmaceuticals Pvt. Ltd.
Prescription Medication2018-04-19
BluePoint Laboratories, Amneal Pharmaceutical Pvt. Ltd, Amneal Pharmaceuticals
Prescription Medication2018-04-18
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals, LLC
Prescription Medication2015-10-06
Amneal Pharmaceuticals, LLC, Identi Pharmaceuticals LLC, Amneal Pharmaceuticals
Prescription Medication2015-10-06
Amneal Pharmaceuticals LLC
Prescription Medication2015-10-01
New Horizon Rx Group, LLC, Amneal Pharmaceuticals
Prescription Medication2014-01-02
New Horizon Rx Group, LLC, Amneal Pharmaceuticals
Prescription Medication2014-01-01
New Horizon Rx Group, LLC, Amneal Pharmaceuticals
Prescription Medication2014-01-01
New Horizon Rx Group, LLC, Amneal Pharmaceuticals
Prescription Medication2013-12-31
Amneal Pharmaceuticals
ZOMIG2013-12-06
Kinray, Aphena Pharma Solutions - Kentucky, LLC, Amneal Pharmaceuticals
Otc Medication2013-06-05
Amneal Pharmaceuticals, Amneal Pharmaceuticals Co. (I) Pvt. Ltd.
Prescription Medication2013-02-25
Amneal Pharmaceuticals
Potassium Chloride2013-02-22
Amneal Pharmaceuticals
Prescription Medication2012-09-07
Amneal Pharmaceuticals
ZOMIG ZMT2012-07-02
Amneal Pharmaceuticals
ZOMIG ZMT2012-07-02
Amneal Pharmaceuticals
ZOMIG2012-07-02
MedVantx, Inc., Amneal Pharmaceuticals, Blenheim Pharmacal, Inc.
Prescription Medication2012-04-24
Amneal Pharmaceuticals
ZOMIG2012-04-02
Amneal Pharmaceuticals
ZOMIG2012-04-02
Amneal Pharmaceuticals
Otc Medication2012-02-22
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC
Otc Medication2012-02-22
Amneal Pharmaceuticals of New York LLC
Otc Medication2012-02-22
Amneal Pharmaceuticals
Otc Medication2012-02-22
Amneal Pharmaceuticals
Otc Medication2012-02-22
Amneal Pharmaceuticals
Otc Medication2012-02-22
H.J. Harkins Company, Inc., Amneal Pharmaceuticals
Prescription Medication2011-12-22
MedVantx, Inc., Amneal Pharmaceuticals, Blenheim Pharmacal, Inc.
Prescription Medication2011-12-20
H.J. Harkins Company, Inc., Amneal Pharmaceuticals
Prescription Medication2011-12-09
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC, Amneal Pharmaceuticals
Prescription Medication2011-11-22
MedVantx, Inc., Amneal Pharmaceuticals, Blenheim Pharmacal, Inc.
Prescription Medication2011-11-14
Amneal Pharmaceuticals
Ibuprofen2011-11-12
H.J. Harkins Company, Inc., Amneal Pharmaceuticals
Prescription Medication2011-09-02
H.J. Harkins Company, Inc., Amneal Pharmaceuticals
Prescription Medication2011-08-31
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-08-24
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc., Targeted Medical Pharma Inc.
Prescription Medication2011-08-15
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc., Targeted Medical Pharma Inc.
Prescription Medication2011-08-15
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc, Targeted Medical Pharma Inc.
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc., Targeted Medical Pharma, Inc.
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc., Targeted Medical Pharma Inc.
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, Targeted Medical Pharma Inc., H.J. Harkins Company, Inc
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, Targeted Medical Pharma Inc., H.J. Harkins Company, Inc.
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc, Targeted Medical Pharma Inc.
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc., Targeted Medical Pharma Inc.
Prescription Medication2011-08-12
Physician Therapeutics LLC, Amneal Pharmaceuticals, H.J. Harkins Company, Inc, Targeted Medical Pharma Inc.
Prescription Medication2011-08-12
RedPharm Drug Inc., Swiss Caps AG, Amneal Pharmaceuticals
Prescription Medication2011-08-08
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-08-05
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-07-27
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-07-27
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-07-27
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-06-02
RedPharm Drug Inc., Amneal Pharmaceuticals
Prescription Medication2011-06-02
Methapharm, Inc., Amneal Pharmaceuticals
Prescription Medication2010-10-18
Amneal Pharmaceuticals
Promethazine Hydrochloride And Dextomethorphan Hydrobromide2010-03-31
Amneal Pharmaceuticals
Cetirizine Hydrochloride2010-01-21
Amneal Pharmaceuticals
Cetirizine Hydrochloride2010-01-21
Amneal Pharmaceuticals
Cetirizine Hydrochloride2010-01-21
Amneal Pharmaceuticals
Cetirizine Hydrochloride2010-01-21
Amneal Pharmaceuticals
Ibuprofen2009-12-16
Amneal Pharmaceuticals
Ibuprofen2009-12-16
Amneal Pharmaceuticals
Metformin Hydrochloride2009-06-01
Amneal Pharmaceuticals
Metformin Hydrochloride2009-06-01
Amneal Pharmaceuticals
Metformin Hydrochloride2009-06-01

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092646785Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey1 DECK CLAMPS FOR VIBROSIFTER 30 IN STAINLESS STEEL1 BOX
2020092522584Rotterdam,Netherlands -> Savannah, GeorgiaPHARMA GOODS / NORLYDA 0,35 MG HS CODE: 30066 039 PKG
2020092327986Rotterdam,Netherlands -> Savannah, GeorgiaPHARMA GOODS / NORLYDA 0,35 MG HS CODE: 30066 039 PKG
2020091772436Rotterdam,Netherlands -> Savannah, GeorgiaPHARMA GOODS / NORLYDA 0,35 MG HS CODE: 30066 039 PKG
2020091490456Rotterdam,Netherlands -> Savannah, GeorgiaPHARMA GOODS / NORLYDA 0,35 MG HS CODE: 30066 039 PKG
2020090933418Mundra,India -> Savannah, Georgia( 20 PKG ) PHARMACEUTICALS TOTAL 20 PACKAGES ONLY HT S: 300490 NAPROXEN TABLETS , USP 500 MG HTS: 300490 N DC 65162-0190-11 QTY.2930 HT S: 300490 HSN CODE 3004 9069 HTS: 300490 USA HTS C ODE 3004.90.9228 HTS: 3004 90 FDA PRODU CT CODE 62 G C A 49 HTS: 300490 ANDA # 7 5927 HTS: 300490 SPIRONOLA CTONE TABLETS,USP25MG20 PKG
2020090538388Nhava Sheva,India -> New York/Newark Area, Newark, New JerseySPARES FOR GRANULATION EQUIPMENTS4 BOX
2020081715159Pusan,South Korea -> New York/Newark Area, Newark, New JerseyOF ELECTRONIC COMPONENT PLACEMENT MACHINES HS CODE 8479 901 PKG

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