Hi Tech Pharmacal Co Inc

FDA Filings

This page includes the latest FDA filings for Hi Tech Pharmacal Co Inc. 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
MEDTECH PRODUCTS INC
Otc Medication2024-07-04
Leadiant Biosciences, Inc.
Prescription Medication2024-05-22
Leadiant Biosciences, Inc., Hi-Tech Pharmacal Co., Inc., Biosint S.p.A.
Prescription Medication2024-05-04
Golden State Medical Supply, Inc., Akorn Operating Company LLC, Akorn AG
Prescription Medication2024-01-27
Golden State Medical Supply, Inc., Akorn AG
Prescription Medication2024-01-27
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp., Ethypharm-Le Grand Quevilly, Ethypharm Châteauneuf-en-Thymerais, FARMEA, SGS France, Whitehouse Analytical Laboratories, LLC, Eurofins Amatsi Analytics, Sharp Corporation, MACFARLAN SMITH LIMITED, SIEGFRIED LIMITED
Prescription Medication2023-12-23
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp.
Prescription Medication2023-12-23
Leadiant Biosciences, Inc., Hi-Tech Pharmacal Co., Inc., Biosint S.p.A.
Prescription Medication2023-11-23
Leadiant Biosciences, Inc.
Prescription Medication2023-11-21
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp., Ethypharm-Le Grand Quevilly, Ethypharm Châteauneuf-en-Thymerais, FARMEA, SGS France, Whitehouse Analytical Laboratories, LLC, Eurofins Amatsi Analytics, Sharp Corporation, MACFARLAN SMITH LIMITED, SIEGFRIED LIMITED
Prescription Medication2023-10-14
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp., Ethypharm-Le Grand Quevilly, Ethypharm Châteauneuf-en-Thymerais, FARMEA, SGS France, Whitehouse Analytical Laboratories, LLC, Eurofins Amatsi Analytics, Sharp Corporation, MACFARLAN SMITH LIMITED, SIEGFRIED LIMITED
Prescription Medication2023-07-25
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp.
Prescription Medication2023-07-25
Leadiant Biosciences, Inc., Hi-Tech Pharmacal Co., Inc., Biosint S.p.A.
Prescription Medication2023-07-21
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp., Ethypharm-Le Grand Quevilly, Ethypharm Châteauneuf-en-Thymerais, FARMEA, SGS France, Whitehouse Analytical Laboratories, LLC, Eurofins Amatsi Analytics, Sharp Corporation, MACFARLAN SMITH LIMITED, SIEGFRIED LIMITED
Prescription Medication2023-07-12
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp.
Prescription Medication2023-07-12
Leadiant Biosciences, Inc., Hi-Tech Pharmacal Co., Inc., Biosint S.p.A.
Prescription Medication2023-07-07
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2023-02-14
Akorn, Akorn Operating Company LLC
Prescription Medication2023-01-20
Akorn, Akorn Operating Company LLC
Prescription Medication2023-01-12
Akorn, Akorn Operating Company LLC
Prescription Medication2023-01-12
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2023-01-07
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp.
Prescription Medication2023-01-01
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp., Ethypharm-Le Grand Quevilly, Ethypharm Châteauneuf-en-Thymerais, FARMEA, SGS France, Whitehouse Analytical Laboratories, LLC, Eurofins Amatsi Analytics, Sharp Corporation, MACFARLAN SMITH LIMITED, SIEGFRIED LIMITED
Prescription Medication2022-12-29
Leadiant Biosciences, Inc., Hi-Tech Pharmacal Co., Inc., Biosint S.p.A.
Prescription Medication2022-12-08
Leadiant Biosciences, Inc.
Prescription Medication2022-11-24
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-11-23
Akorn, Akorn Operating Compnay LLC
Otc Medication2022-11-16
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-11-16
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-11-16
Akorn, Akorn Operating Company LLC
Prescription Medication2022-11-12
Akorn, Akorn Operating Company LLC
Prescription Medication2022-11-12
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-11-12
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-11-11
Akorn, Akorn Operating Company LLC
Prescription Medication2022-11-03
Doc Rx, Enovachem Pharmaceuticals, Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-10-22
Hi-Tech Pharmacal Co., Inc.
Otc Medication2022-10-18
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-10-18
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-10-18
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-10-15
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Otc Medication2022-10-15
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-10-15
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-09-20
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-09-20
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-09-20
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-09-20
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-09-20
Akorn, Akorn Operating Company LLC
Prescription Medication2022-09-20
Akorn
Animal Medication2022-09-19
Akorn, Akorn Operating Company LLC
Prescription Medication2022-09-16
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-09-16
Akorn, Akorn Operating Company LLC
Prescription Medication2022-09-16
Golden State Medical Supply, Inc., Akorn Operating Company LLC, Akorn AG
Prescription Medication2022-08-05
Golden State Medical Supply, Inc., Akorn AG
Prescription Medication2022-08-05
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp., Ethypharm-Le Grand Quevilly, Ethypharm Châteauneuf-en-Thymerais, FARMEA, SGS France, Whitehouse Analytical Laboratories, LLC, Eurofins Amatsi Analytics, Sharp Corporation, MACFARLAN SMITH LIMITED, SIEGFRIED LIMITED
Prescription Medication2022-07-07
Hi-Tech Pharmacal Co. Inc., Ethypharm USA Corp.
Prescription Medication2022-07-07
Leadiant Biosciences, Inc.
Prescription Medication2022-06-10
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-06-03
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC, Akorn AG
Prescription Medication2022-06-02
Akorn, Akorn Operating Company LLC
Prescription Medication2022-06-02
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC, Akorn AG
Prescription Medication2022-06-02
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-05-28
Akorn, Akorn Operating Company LLC
Prescription Medication2022-05-28
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-05-28
Akorn, Akorn Operating Company LLC
Prescription Medication2022-05-28
Hi-Tech Pharmacal Co., Inc., Calalent Pharma Solutions
Prescription Medication2022-05-28
Akorn, Akorn Operating Company LLC
Prescription Medication2022-05-28
Akorn, Akorn Operating Company LLC
Prescription Medication2022-05-27
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-05-27
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-05-27
Akorn, Akorn Operating Company LLC
Prescription Medication2022-05-27
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-05-26
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-05-19
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC, Mikart, Inc.
Prescription Medication2022-03-23
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-18
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-18
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-03-18
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-03-18
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-18
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-17
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-17
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-17
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-17
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-17
Hi-Tech Pharmacal Co., Inc., Akorn Operating Co. LLC
Prescription Medication2022-03-16
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-16
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-16
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-03-16
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-16
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Otc Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-15
Hi-Tech Pharmacal Co., Inc.
Prescription Medication2022-03-12
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-03-12
Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC
Prescription Medication2022-03-12
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-12
Akorn, Akorn Operating Company LLC
Prescription Medication2022-03-12
Hi-Tech Pharmacal Co., Inc.
Azelastine Hydrochloride2019-08-27
Hi-Tech Pharmacal Co., Inc.
Azelastine Hydrochloride2019-05-18
Hi-Tech Pharmacal Co., Inc.
Loteprednol Etabonate2019-04-18
Hi-Tech Pharmacal Co., Inc.
Dorzolamide Hydrochloride And Timolol Maleate2019-02-01
Hi-Tech Pharmacal Co., Inc.
Diclofenac Sodium2018-11-30
Hi-Tech Pharmacal Co., Inc.
Bimatoprost2018-11-12
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2018-11-05
Hi-Tech Pharmacal Co., Inc.
Bimatoprost2018-10-10
Hi-Tech Pharmacal Co., Inc.
Fluticasone Propionate2018-08-23
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2017-10-30
Hi-Tech Pharmacal Co., Inc.
Oxycodone Hydrochloride2017-08-10
Hi-Tech Pharmacal Co., Inc.
Oxycodone Hydrochloride2017-08-07
Hi-Tech Pharmacal Co., Inc.
Trifluridine2017-07-28
Hi-Tech Pharmacal Co., Inc.
Morphine Sulfate2017-07-06
Hi-Tech Pharmacal Co., Inc.
Megestrol Acetate2017-04-10
Hi-Tech Pharmacal Co., Inc.
Ibuprofen2016-11-28
Hi-Tech Pharmacal Co., Inc.
Famotidine2016-03-16
Hi-Tech Pharmacal Co. Inc
Buprenorphine And Naloxone2016-01-07
Hi-Tech Pharmacal Co. Inc
Buprenorphine And Naloxone2016-01-07
Hi-Tech Pharmacal Co., Inc.
Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate2015-06-16
Hi-Tech Pharmacal Co., Inc.
Promethazine Hydrochloride And Phenylephrine Hydrochloride2015-06-16
Hi-Tech Pharmacal Co., Inc.
Calcipotriene2014-10-06
Hi-Tech Pharmacal Co., Inc.
Gatifloxacin2014-10-06
Hi-Tech Pharmacal Co., Inc.
Bromfenac2014-01-22
Hi-Tech Pharmacal Co., Inc.
Protriptyline Hydrochloride2013-10-28
Hi-Tech Pharmacal Co., Inc.
Protriptyline Hydrochloride2013-10-28
Hi-Tech Pharmacal Co., Inc.
Paregoric2012-08-06
Hi-Tech Pharmacal Co., Inc.
Lidocaine2012-03-12
Hi-Tech Pharmacal Co., Inc.
Guaifenesin2012-03-07
Hi-Tech Pharmacal Co., Inc.
Dextromethorphan HBr And Guaifenesin2012-03-07
Hi-Tech Pharmacal Co., Inc.
Levetiracetam2012-02-28
Hi-Tech Pharmacal Co., Inc.
Lorazepam2012-01-30
Hi-Tech Pharmacal Co., Inc.
Nystatin2012-01-27
Hi-Tech Pharmacal Co., Inc.
Levofloxacin2011-06-21
Hi-Tech Pharmacal Co., Inc.
Ranitidine2011-03-22
Hi-Tech Pharmacal Co., Inc.
Gabapentin2011-02-23
Hi-Tech Pharmacal Co. Inc.
Buprenorphine Hydrochloride2010-09-24
Hi-Tech Pharmacal Co. Inc.
Buprenorphine Hydrochloride2010-09-24
Hi-Tech Pharmacal Co., Inc.
Guaiatussin AC2010-09-08
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2010-06-07
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2010-06-07
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2010-06-07
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2010-06-07
Hi-Tech Pharmacal Co., Inc.
Clobetasol Propionate2010-06-07
HI TECH PHARMACAL CO INC
Neomycin Sulfate2010-03-12
Hi-Tech Pharmacal Co., Inc.
Acetic Acid2010-01-22
Hi-Tech Pharmacal Co., Inc.
Hydrocortisone And Acetic Acid2009-06-04
Hi-Tech Pharmacal Co., Inc.
Dorzolamide Hydrochloride And Timolol Maleate2008-10-28
Hi-Tech Pharmacal Co., Inc.
Dorzolamide Hydrochloride2008-10-28
Hi-Tech Pharmacal Co., Inc.
Ofloxacin2008-03-17
Hi-Tech Pharmacal Co., Inc.
Hydrocodone Bitartrate And Homatropine Methylbromide2008-02-08
Hi-Tech Pharmacal Co., Inc.
Fluticasone Propionate2008-01-16
Hi-Tech Pharmacal Co., Inc.
Ciclopirox2007-09-18
Hi-Tech Pharmacal Co., Inc.
Levocarnitine2005-11-01
Hi-Tech Pharmacal Co., Inc.
Acyclovir2005-06-07
Hi-Tech Pharmacal Co., Inc.
Ofloxacin2004-05-14
Hi-Tech Pharmacal Co., Inc.
Lidocaine And Prilocaine2003-09-25
Hi-Tech Pharmacal Co., Inc.
Prednisolone Sodium Phosphate2003-03-26
Hi-Tech Pharmacal Co., Inc.
Prednisolone2003-02-27
Hi-Tech Pharmacal Co., Inc.
Timolol Maleate2002-09-10
Hi-Tech Pharmacal Co., Inc.
Anestacon2001-11-05
Hi-Tech Pharmacal Co., Inc.
Promethazine Hydrochloride1998-09-25
Hi-Tech Pharmacal Co., Inc.
Albuterol Sulfate1998-01-30
Hi-Tech Pharmacal Co., Inc.
Albuterol Sulfate1998-01-15
Hi-Tech Pharmacal Co., Inc.
Sulfamethoxazole And Trimethoprim1997-12-29
Hi-Tech Pharmacal Co., Inc.
Sulfamethoxazole And Trimethoprim1997-12-29
Hi-Tech Pharmacal Co., Inc.
Cimetidine Hydrochloride Oral Solution1997-10-28
Hi-Tech Pharmacal Co., Inc.
Promethazine Hydrochloride And Codeine Phosphate1997-08-26
Hi-Tech Pharmacal Co., Inc.
Docu Liquid1997-08-01
Hi-Tech Pharmacal Co., Inc.
Eye Wash1997-01-06
Hi-Tech Pharmacal Co., Inc.
Minoxidil1996-12-24
Hi-Tech Pharmacal Co., Inc.
Promethazine Hydrochloride And Dextromethophan Hydrobromide1996-07-31
Hi-Tech Pharmacal Co., Inc.
Chlorhexidine Gluconate1996-05-07
Hi-Tech Pharmacal Co., Inc.
Acetaminophen And Codeine Phosphate1996-04-26
Hi-Tech Pharmacal Co., Inc.
Loperamide Hydrochloride1995-11-17
Hi-Tech Pharmacal Co., Inc.
Lidocaine Hydrochloride1995-07-10
Hi-Tech Pharmacal Co., Inc.
Lactulose1995-07-03
Hi-Tech Pharmacal Co., Inc.
Lactulose1995-07-03
Hi-Tech Pharmacal Co., Inc.
Valproic Acid1995-01-13
Hi-Tech Pharmacal Co., Inc.
Amantadine Hydrochloride1994-10-28
Hi-Tech Pharmacal Co., Inc.
HydrOXYzine Hydrochloride1994-10-28
Hi-Tech Pharmacal Co., Inc.
Levocarnitine1986-04-10

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