Is Imipramine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Imipramine, including TOFRANIL 25 MG 50 TAB (25 mg, Tablet, SAR 16.85).

Is Imipramine approved by the US FDA?

Drugs@FDA lists 45 application product lines for Imipramine, including IMIPRAMINE HYDROCHLORIDE (Prescription); IMIPRAMINE HYDROCHLORIDE (Prescription); IMIPRAMINE HYDROCHLORIDE (Prescription); IMIPRAMINE HYDROCHLORIDE (Prescription); IMIPRAMINE HYDROCHLORIDE (Prescription).

Active substance

Imipramine

SFDA 6
US FDA 45
Health Canada 8
US price lines 6
NHS prices 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TOFRANIL 25 MG 50 TAB	25 mg	Tablet · Oral use	50 Tablet Container	SAR 16.85	Generic · Prescription	AMDIPHARMA	Valid
IMIPREX 10 MG TAB	10 mg	Tablet · Oral use	100 Tablet Container	SAR 16.40	NCE · Prescription	ALPHARMA APS	Withdrawn by MAH · Not Marketed
IMIPREX 25 MG. TAB	25 mg	Tablet · Oral use	100 Tablet Container	SAR 20.35	NCE · Prescription	AXELLIA PHARMACEUTICALS	Withdrawn by MAH · Not Marketed
TOFRANIL 10 MG TAB	10 mg	Tablet · Oral use	60 Tablet Container	SAR 15.95	Generic · Prescription	AMDIPHARMA	Withdrawn by regulatory authority · Not Marketed
TOFRANIL 10 MG TAB	10 mg	Tablet · Oral use	60 Tablet Container	SAR 15.95	Generic · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
TOFRANIL 25 MG 50 TAB	25 mg	Tablet · Oral use	50 Tablet Container	SAR 16.85	Generic · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ABDOMINAL SPASM; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); DEPRESSION; DIABETIC NEUROPATHY; DYSPEPSIA; IRRITABLE BOWEL SYNDROME; LOW BACK PAIN; NEUROPATHIC PAIN; NOCTURNAL ENURESIS; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; SICKLE CELL DISEASE - PAIN MANAGEMENT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
IMIPRAMINE HYDROCHLORIDE	25MG	tablet · oral	SANDOZ	Prescription	20 Apr 1976
IMIPRAMINE HYDROCHLORIDE	10MG	tablet · oral	SANDOZ	Prescription	20 Apr 1976
IMIPRAMINE HYDROCHLORIDE	50MG	tablet · oral	SANDOZ	Prescription	20 Apr 1976
IMIPRAMINE HYDROCHLORIDE	25MG	tablet · oral	STRIDES PHARMA INTL	Prescription	21 Oct 1983
IMIPRAMINE HYDROCHLORIDE	50MG	tablet · oral	STRIDES PHARMA INTL	Prescription	21 Oct 1983
IMIPRAMINE HYDROCHLORIDE	10MG	tablet · oral	STRIDES PHARMA INTL	Prescription	21 Oct 1983
IMIPRAMINE HYDROCHLORIDE	25MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	5 Jun 1990
IMIPRAMINE HYDROCHLORIDE	50MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	5 Jun 1990
IMIPRAMINE HYDROCHLORIDE	50MG; 25MG; 10MG	tablet · oral	OXFORD PHARMS	Prescription	28 Feb 2008
IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE; EQ 100MG HYDROCHLORIDE; EQ 125MG HYDROCHLORIDE; EQ 150MG HYDROCHLORIDE	capsule · oral	LUPIN LTD	Prescription	16 Apr 2010
IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE; EQ 100MG HYDROCHLORIDE; EQ 125MG HYDROCHLORIDE; EQ 150MG HYDROCHLORIDE	capsule · oral	HIKMA PHARMS	Prescription	16 Apr 2010
IMIPRAMINE HYDROCHLORIDE	10MG; 25MG; 50MG	tablet · oral	LEADING	Prescription	24 Oct 2012
PRESAMINE	25MG; 10MG; 50MG	tablet · oral	SANOFI AVENTIS US	Discontinued	16 Apr 1959
TOFRANIL	12.5MG/ML	injectable · injection	NOVARTIS	Discontinued	2 Oct 1959
TOFRANIL-PM	EQ 75MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 150MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 125MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	SPECGX LLC	Discontinued	11 Mar 1973
IMIPRAMINE HYDROCHLORIDE	10MG; 50MG; 25MG	tablet · oral	TEVA	Discontinued	27 Jun 1974
JANIMINE	10MG; 25MG; 50MG	tablet · oral	ABBOTT	Discontinued	15 Nov 1974
IMIPRAMINE HYDROCHLORIDE	10MG; 25MG; 50MG	tablet · oral	ROXANE	Discontinued	5 Aug 1977
PRAMINE	10MG; 25MG; 50MG	tablet · oral	ALRA	Discontinued	19 Jun 1978
IMIPRAMINE HYDROCHLORIDE	25MG	tablet · oral	WATSON LABS	Discontinued	16 Oct 1978
IMIPRAMINE HYDROCHLORIDE	50MG	tablet · oral	WATSON LABS	Discontinued	30 Oct 1978
IMIPRAMINE HYDROCHLORIDE	10MG	tablet · oral	WATSON LABS	Discontinued	4 Feb 1981
IMIPRAMINE HYDROCHLORIDE	50MG	tablet · oral	SANDOZ	Discontinued	13 Mar 1981
IMIPRAMINE HYDROCHLORIDE	10MG	tablet · oral	SANDOZ	Discontinued	13 Mar 1981
IMIPRAMINE HYDROCHLORIDE	50MG	tablet · oral	VANGARD	Discontinued	4 Jan 1982

20 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-IMIPRAMINE TABLETS	00312797	25 MG	TABLET · ORAL	APOTEX INC
APO-IMIPRAMINE TABLETS	00326852	50 MG	TABLET · ORAL	APOTEX INC
APO-IMIPRAMINE TABLETS	00360201	10 MG	TABLET · ORAL	APOTEX INC
APO-IMIPRAMINE TABLETS	00644579	75 MG	TABLET · ORAL	APOTEX INC
JAMP IMIPRAMINE	02546337	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP IMIPRAMINE	02546345	25 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP IMIPRAMINE	02546353	50 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP IMIPRAMINE	02546361	75 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	IMIPRAMINE HCL 10 MG TABLET	$0.06983	per EA	23 Sep 2026
US NADAC	IMIPRAMINE HCL 25 MG TABLET	$0.08877	per EA	23 Sep 2026
US NADAC	IMIPRAMINE HCL 50 MG TABLET	$0.15567	per EA	23 Sep 2026
US NADAC	IMIPRAMINE PAMOATE 100 MG CAP	$3.65022	per EA	23 Sep 2026
US NADAC	IMIPRAMINE PAMOATE 150 MG CAP	$2.6911	per EA	23 Sep 2026
US NADAC	IMIPRAMINE PAMOATE 75 MG CAP	$3.23863	per EA	23 Sep 2026
NHS Drug Tariff	Imipramine 10mg tablets	£3.25	28 tablet	1 Oct 2026
NHS Drug Tariff	Imipramine 25mg tablets	£1.86	28 tablet	1 Oct 2026
NHS Drug Tariff	Imipramine 25mg/5ml oral solution sugar free	£250.00	150 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.