Novitium Pharma L L C

FDA Filings

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

FDA Filings

Device Company	Device	Date
Pirfenidone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-05-11
Hydrocortisone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-05-07
DAPSONE ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-04-29
Paroxetine ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-04-29
TEZRULY ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-04-19
Indomethacin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-04-10
Rifabutin Novitium Pharma LLC	Prescription Medication	2025-04-10
Naproxen ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-04-10
Naproxen Oral Suspension ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-04-02
Ontralfy Fidelity BioPharma Co., Novitium Pharma LLC., Sun Pharmaceutical Industries Limited, Perritt Laboratories, Inc.	Prescription Medication	2025-03-31
Finasteride and Tadalafil ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-03-26
Thiothixene Novitium Pharma LLC	Prescription Medication	2025-02-27
Acetazolamide Novitium Pharma LLC	Prescription Medication	2025-02-14
Sulfamethoxazole and Trimethoprim ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-02-06
INZIRQO ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-02-06
SOVUNA ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-01-31
Prochlorperazine Maleate ANI Pharmaceuticals, Inc.	Prescription Medication	2025-01-31
Thiothixene Novitium Pharma LLC	Prescription Medication	2025-01-25
Fluphenazine Hydrochloride Novitium Pharma LLC	Prescription Medication	2025-01-25
Lacosamide ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-01-19
Nabumetone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-01-12
Clorazepate Dipotassium ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2025-01-12
Prednisone Novitium Pharma LLC	Prescription Medication	2025-01-09
Prucalopride ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-12-29
Oxybutynin Chloride Novitium Pharma LLC	Prescription Medication	2024-11-27
Estradiol ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-10-30
Tranylcypromine Marlex Pharmaceuticals, Inc.	Prescription Medication	2024-10-19
Selegiline Hydrochloride Marlex Pharmaceuticals, Inc.	Prescription Medication	2024-10-19
Rifabutin Marlex Pharmaceuticals, Inc.	Prescription Medication	2024-10-18
Nitrofurantoin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-10-10
FLUPHENAZINE HYDROCHLORIDE Marlex Pharmaceuticals, Inc.	Prescription Medication	2024-10-09
Digoxin Marlex Pharmaceuticals, Inc.	Prescription Medication	2024-10-04
Bisoprolol Fumarate and Hydrochlorothiazide Marlex Pharmaceuticals, Inc.	Prescription Medication	2024-10-04
ATENOLOL AND CHLORTHALIDONE MARLEX PHARMACEUTICALS, INC	Prescription Medication	2024-10-04
Enalapril maleate oral solution Bionpharma Inc., Novitium Pharma LLC, CoreRx Inc.	Prescription Medication	2024-10-03
Estradiol ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-09-26
Fluoxetine Hydrochloride ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-09-21
Ketoconazole ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-09-20
SOVUNA ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-09-13
Sulfamethoxazole and Trimethoprim ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-08-23
TEZRULY ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-08-02
Meloxicam Novitium Pharma LLC	Prescription Medication	2024-07-27
L-Glutamine ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-07-12
Megestrol Acetate ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-07-12
Meloxicam Novitium Pharma LLC	Prescription Medication	2024-07-09
Tadalafil ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-07-09
Prochlorperazine Maleate ANI Pharmaceuticals, Inc.	Prescription Medication	2024-07-09
Levofloxacin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-06-25
Naproxen ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-06-20
Lacosamide PAI Holdings, LLC, Novitium Pharma LLC, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	Prescription Medication	2024-06-01
Lacosamide PAI Holdings, LLC, Novitium Pharma LLC, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	Prescription Medication	2024-05-22
Levocarnitine Novitium Pharma LLC	Prescription Medication	2024-05-22
Digoxin Novitium Pharma LLC	Prescription Medication	2024-05-11
Sulfamethoxazole and Trimethoprim ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-05-11
Estradiol ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-04-27
Chlorzoxazone Cameron Pharmaceuticals, Novitium Pharma, LLC	Prescription Medication	2024-04-17
SOVUNA ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-04-15
Estradiol ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-28
Levofloxacin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-28
Nitrofurantoin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-23
Clorazepate Dipotassium ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-22
Bisoprolol Fumarate and Hydrochlorothiazide Novitium Pharma LLC	Prescription Medication	2024-03-22
Atenolol and Chlorthalidone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-22
Sulfamethoxazole and Trimethoprim ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-16
Pirfenidone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-12
Dexamethasone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-05
Prednisone Novitium Pharma LLC	Prescription Medication	2024-03-02
Prednisone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-03-02
Pirfenidone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-02-29
Lacosamide ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-02-03
Sildenafil Novitium Pharma LLC	Prescription Medication	2024-02-03
Indomethacin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-01-20
Indomethacin ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2024-01-18
Prochlorperazine Maleate ANI Pharmaceuticals, Inc.	Prescription Medication	2024-01-10
Misoprostol ANI Pharmaceuticals, Inc.	Prescription Medication	2024-01-10
Enalapril maleate oral solution Bionpharma Inc., Novitium Pharma LLC, CoreRx Inc.	Prescription Medication	2023-12-28
ATENOLOL AND CHLORTHALIDONE MARLEX PHARMACEUTICALS, INC	Prescription Medication	2023-12-05
Carbamazepine ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-11-18
Lidocaine Hydrochloride Marlex Pharmaceuticals, Inc.	Prescription Medication	2023-11-16
Clorazepate Dipotassium ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-11-04
Pirfenidone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-10-24
Paroxetine ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-10-19
Dexamethasone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-10-10
Dexamethasone ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-10-03
Prednisone Novitium Pharma LLC	Prescription Medication	2023-10-03
Famotidine ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-10-03
Fluoxetine Hydrochloride ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-10-03
Levocarnitine ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-09-22
SOVUNA ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-09-20
Valsartan ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-09-19
Fludrocortisone Acetate NorthStar Rx LLC, Novitium Pharma LLC	Prescription Medication	2023-09-14
Estradiol ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-09-10
Sildenafil Citrate ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-09-06
Estradiol ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-08-31
Lacosamide PAI Holdings, LLC, Novitium Pharma LLC, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	Prescription Medication	2023-08-31
Clorazepate Dipotassium ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-08-25
Lacosamide PAI Holdings, LLC, Novitium Pharma LLC, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	Prescription Medication	2023-08-25
Fluoxetine Hydrochloride ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-08-06
Prednisone Novitium Pharma LLC	Prescription Medication	2023-07-22
Potassium chloride ANI Pharmaceuticals, Inc., Novitium Pharma LLC	Prescription Medication	2023-07-22
NDC 70954-051 Novitium Pharma LLC	Felbamate	2022-07-15
NDC 70954-159 Novitium Pharma LLC	Clorazepate Dipotassium	2022-06-16
NDC 70954-158 Novitium Pharma LLC	Clorazepate Dipotassium	2022-06-16
NDC 70954-172 Novitium Pharma LLC	Hydroxychloroquine Sulfate	2022-01-14
NDC 70954-171 Novitium Pharma LLC	Hydroxychloroquine Sulfate	2022-01-14
NDC 70954-041 Novitium Pharma LLC	Rifabutin	2021-12-17
NDC 70954-120 Novitium Pharma LLC	Carglumic Acid	2021-10-13
NDC 70954-056 Novitium Pharma LLC	Prednisone	2021-07-06
NDC 70954-151 Novitium Pharma LLC	Naproxen Oral Suspension	2021-03-12
NDC 70954-077 Novitium Pharma LLC	Meloxicam	2021-03-10
NDC 70954-076 Novitium Pharma LLC	Meloxicam	2021-03-10
NDC 70954-188 Novitium Pharma LLC	Acyclovir	2020-07-13
NDC 70954-061 Novitium Pharma LLC	Prednisone	2019-11-15
NDC 70954-060 Novitium Pharma LLC	Prednisone	2019-11-15
NDC 70954-059 Novitium Pharma LLC	Prednisone	2019-11-15
NDC 70954-058 Novitium Pharma LLC	Prednisone	2019-11-15
NDC 70954-057 Novitium Pharma LLC	Prednisone	2019-11-15
NDC 70954-034 Novitium Pharma LLC	Acetazolamide	2019-10-17
NDC 70954-033 Novitium Pharma LLC	Acetazolamide	2019-10-17
NDC 70954-154 Novitium Pharma LLC	Digoxin	2019-10-04
NDC 70954-085 Novitium Pharma LLC	Chlorzoxazone	2019-09-12
NDC 70954-140 Novitium Pharma LLC	Levocarnitine	2019-08-14
NDC 70954-139 Novitium Pharma LLC	Levocarnitine	2019-08-14
NDC 70954-168 Novitium Pharma LLC	Sildenafil	2019-05-31
NDC 70954-075 Novitium Pharma LLC	Sirolimus	2019-05-21
NDC 70954-017 Novitium Pharma LLC	Thiothixene	2019-04-05
NDC 70954-016 Novitium Pharma LLC	Thiothixene	2019-04-05
NDC 70954-015 Novitium Pharma LLC	Thiothixene	2019-04-05
NDC 70954-014 Novitium Pharma LLC	Thiothixene	2019-04-05
NDC 70954-148 Novitium Pharma LLC	Pyridostigmine	2019-03-11
NDC 70954-036 Novitium Pharma LLC	Clotrimazole	2019-02-18
NDC 70954-212 Novitium Pharma LLC	TRIHEXYPHENIDYL HYDROCHLORIDE	2019-01-28
NDC 70954-211 Novitium Pharma LLC	TRIHEXYPHENIDYL HYDROCHLORIDE	2019-01-28
NDC 70954-002 Novitium Pharma LLC	Ranitidine Hydrochloride	2018-11-23
NDC 70954-001 Novitium Pharma LLC	Ranitidine Hydrochloride	2018-11-23
NDC 70954-079 Novitium Pharma LLC	Albuterol	2018-10-30
NDC 70954-078 Novitium Pharma LLC	Albuterol	2018-10-30
NDC 70954-021 Novitium Pharma LLC	Prazosin Hydrochloride	2018-10-03
NDC 70954-020 Novitium Pharma LLC	Prazosin Hydrochloride	2018-10-03
NDC 70954-019 Novitium Pharma LLC	Prazosin Hydrochloride	2018-10-03
NDC 70954-010 Novitium Pharma LLC	Nitisinone	2018-10-01
NDC 70954-009 Novitium Pharma LLC	Nitisinone	2018-10-01
NDC 70954-008 Novitium Pharma LLC	Nitisinone	2018-10-01
NDC 70954-136 Novitium Pharma LLC	DAPSONE	2018-01-15
NDC 70954-135 Novitium Pharma LLC	DAPSONE	2018-01-15
NDC 70954-005 Novitium Pharma LLC	Oxybutynin Chloride	2017-11-15

Similar & Related FDA Registered Companies

• ANI Pharmaceuticals, Inc.
• Fidelity BioPharma Co.
• Sun Pharmaceutical Industries Limited
• Perritt Laboratories, Inc.
• Marlex Pharmaceuticals, Inc.
• Bionpharma Inc.
• CoreRx Inc.
• PAI Holdings, LLC
• PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
• Cameron Pharmaceuticals
• NorthStar Rx LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081892198	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PIBA AND DIP TUBE ASSEMBLED .	20 PKG
2019071728641	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PIBA AND DIP TUBE ASSEMBLED AND INDIVIDUALLY PACKED	22 PKG
2019070359914	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PIBA AND DIP TUBE ASSEMBLED AND INDIVIDUALLY PACKED	22 PKG
2019070271768	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PIBA AND DIP TUBE ASSEMBLED AND INDIVIDUALLY PACKED	22 PKG
2018080615096	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PIBA AND DIP TUBE ASSEMBLED .	20 PKG
2018072834088	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PIBA AND DIP TUBE ASSEMBLED .	20 PKG
2018010914575	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	BOROSILICATE LABORATORY GLASSWARE	735 CTN