Ferrous fumarate

Generic Name: Ferrous fumarate

Brand Names: Aurovela Fe, Concept Ob, Hailey Fe 1.5/30 28 Day, Hematogen, Microgestin Fe 1/20 28 Day, Pregvit, Tandem, Tandem Plus, Tarina 24 Fe 1/20 28 Day

Drug Type: Small Molecule

Chemical Formula: C_₄H_₂FeO_₄

CAS Number: 141-01-5

Unique Ingredient Identifier: R5L488RY0Q

Overview

Used in treatment of iron deficiency anemia.

Indication

Used in preventing and treating iron-deficiency anemia.

Associated Conditions

Folic acid antagonist overdose
Iron Deficiency (ID)
Iron Deficiency Anemia (IDA)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.	2022/10/14	NCT05581420	Not Applicable	Recruiting	Leiden University Medical Center
Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease	2022/07/13	NCT05456932	Phase 4	Recruiting	Leiden University Medical Center
The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.	2022/03/14	NCT05278793	Phase 4	UNKNOWN	Martini Hospital Groningen
Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia	2019/10/17	NCT04130828	Phase 3	Completed	Prince of Songkla University
Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial	2017/09/28	NCT03295851	Phase 4	UNKNOWN	Singapore General Hospital
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women	2017/07/11	NCT03212781	Phase 3	Completed	Assiut University
Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass	2014/10/22	NCT02271997	Phase 4	Completed	Rijnstate Hospital
Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia	2014/09/18	NCT02243735	Phase 4	UNKNOWN	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Iron Absorption Trial	2014/08/29	NCT02228902	Phase 4	Completed	Rijnstate Hospital
The Use of Iron Therapy for Patients With Anemia After Caesarean Section	2013/11/03	NCT01975272	Phase 4	Terminated	Maastricht University Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PRENATAL PLUS	AvPAK	50268-677	ORAL	27 mg in 1 1	4/12/2022
BACMIN	Marnel Pharmaceuticals, Inc.	0682-3001	ORAL	27 mg in 1 1	5/2/2014
C-Nate DHA	Centurion Labs, LLC	23359-105	ORAL	28 mg in 1 1	1/22/2024
Chromagen	Avion Pharmaceuticals, LLC	75854-320	ORAL	50 mg in 1 1	1/18/2021
PRENATAL PLUS	Carilion Materials Management	68151-2640	ORAL	27 mg in 1 1	4/1/2013
PureVit DualFe Plus	PureTek Corporation	59088-112	ORAL	53 mg in 1 1	1/11/2023
Keylosa	Novian Pharmaceuticals	83146-003	ORAL	27 mg in 1 1	10/6/2023
PNV-DHA	Acella Pharmaceuticals, LLC	42192-321	ORAL	27 mg in 1 1	1/5/2018
PRENATAL PLUS	Amneal Pharmaceuticals LLC	65162-668	ORAL	27 mg in 1 1	3/29/2022
Concept OB	U.S. Pharmaceutical Corporation	52747-620	ORAL	42.5 mg in 1 1	7/13/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FBC FILMTAB	OLIC (THAILAND) LTD, UNICHEM PHARMACEUTICALS LTD	SIN05814P	TABLET, FILM COATED	200 mg	5/3/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Ferropods	329091	Boucher & Muir Pty Ltd	Medicine	A	1/22/2020
BLACKMORES SUPERKIDS MULTI CHEWABLES	289492	Blackmores Ltd	Medicine	A	5/30/2017
Blackmores Bio Iron (NZ)	143952	Blackmores Ltd	Medicine	A	8/29/2007
Calcium + D3 Corbiere	291608	Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare	Medicine	A	7/17/2017
HKSG Swisse Kids Multi	321304	Swisse Wellness Pty Ltd	Medicine	A	8/5/2019
Supervite Multivitamin + Ginseng	312495	Mysekyo Australia Pty Ltd	Medicine	A	12/13/2018
Swisse Ultivite Children's Multivitamin	276713	Swisse Wellness Pty Ltd	Medicine	A	6/17/2016
Pro Saffron Mood	377510	The Better Health Company (Australia) PTY	Medicine	A	11/5/2021
Swisse Men's Multivitamins	351919	Swisse Wellness Pty Ltd	Medicine	A	12/18/2020
Swisse Ultivite Women's High Potency Multivitamin	369430	Swisse Wellness Pty Ltd	Medicine	A	6/16/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FERROUS FUMARATE TAB 200MG	shoppers drug mart inc.	00415030	Tablet - Oral	200 MG / TAB	12/31/1977
CHILDREN'S VITAMINS W IRON CHEWABLE	vita health products inc	00787116	Tablet - Oral	4 MG	12/31/1990
FUSION AM FORMULA TAB	l & s research corporation	01961152	Tablet - Oral	4 MG / TAB	12/31/1993
NOVO-FUMAR 200MG	novopharm limited	00021431	Tablet - Oral	200 MG	12/31/1967
MATERNA TAB	cyanamid canada inc.	01900587	Tablet - Oral	60 MG / TAB	12/31/1991
BUGS BUNNY CHEW MULTI VIT PLUS IRON	miles canada inc. - consumer health care division	00570532	Tablet - Oral	12 MG / TAB	12/31/1983
CENTRUM JR. COMPLETE	lederle consumer health products	00701076	Tablet - Oral	4 MG / TAB	12/31/1986
FLINTSTONES COMPLETE	miles canada inc. - consumer health care division	00585823	Tablet - Oral	4 MG	12/31/1983
COMPLETE FORMULA FOR ADULTS TAB	ksl pharmaceuticals	02047527	Tablet - Oral	10 MG / TAB	12/31/1995
CHILDREN'S CHEWABLE MULTIPLE VIT.PLUS IRON	stanley pharmaceuticals, a division of vita health products inc.	02202069	Tablet - Oral	4 MG	10/10/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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