Aminophylline

Sold as Aminophyllin, Somophyllin, Aminophylline In Sodium Chloride 0.45% In Plastic Container. Every FDA application for this active ingredient: 3 branded and 63 generic.

As of Nov 15, 2026, FDA lists 66 applications for Aminophylline (sold as Aminophyllin, Somophyllin, Aminophylline In Sodium Chloride 0.45% In Plastic Container), first approved Apr 19, 1940, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 19, 1940
Applications: 66
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $342K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Aminophylline	Part B	$342K	+2%	36,018

Clinical Trials

10 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and ApplicationSevere High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema · Tibet Autonomous Region People's Hospital	Not applicable	Not yet recruiting	Jun 10, 2026
Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRSRenal Stones, Retrograde Intrarenal Surgery · Beni-Suef University	Phase 2	Recruiting	Jun 3, 2026
Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous AnuriaAcute Calculous Anuria, Ureteral Calculi · Beni-Suef University	Phase 2	Recruiting	Jun 1, 2026
Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.Pediatric Urolithiasis, Distal Ureteral Stone · Beni-Suef University	Phase 2	Recruiting	Jun 1, 2026
Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical ProceduresDiuretic Effect, Aminophylline · Cairo University	Not applicable	Recruiting	Jan 16, 2026
Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)High Altitude Pulmonary Hypertension · Novlead Inc.	Not applicable	Recruiting	Feb 28, 2025
Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy ProcedureStones, Kidney, Ureteric Injury · Ain Shams University	Not applicable	Recruiting	Feb 17, 2025
Efficacy of Intra-Ureteric Aminophylline Installation After Failed Stone Accessibility by Semi-rigid Ureteroscopy. Prospective TrialUreterocopic Lithotripsy, Stone Ureter · Al-Azhar University	Not applicable	Recruiting	Dec 11, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 19, 1940	AminophyllinNDA 2386 · New formulation or manufacturer	Gd Searle LLC	15	Discontinued
Nov 26, 1975	AminophyllineANDA 84540	Hikma	20	Discontinued
Dec 17, 1975	AminophyllineANDA 84588	Chartwell Molecular	1	Discontinued
Mar 16, 1976	AminophyllineANDA 84577	Impax Labs	0	Discontinued
Mar 19, 1976	AminophyllineANDA 84575	Impax Labs	0	Discontinued
May 28, 1976	AminophyllineANDA 84563	Valeant Pharm Intl	0	Discontinued
May 28, 1976	AminophyllineANDA 85003	Hikma	26	Discontinued
Jun 15, 1976	AminophyllineANDA 84674	Halsey	2	Discontinued
Oct 27, 1976	AminophyllineANDA 85284	Kv Pharm	0	Discontinued
Oct 29, 1976	AminophyllineANDA 85289	Kv Pharm	0	Discontinued
Dec 22, 1976	AminophyllineANDA 85261	Ani Pharms	15	Discontinued
Nov 21, 1979	PhyllocontinANDA 86760	Pharm Res Assoc	3	Discontinued
Sep 30, 1980	Somophyllin-DfANDA 87045	Fisons	2	Discontinued
Feb 11, 1981	AminophyllineANDA 87239	Elkins Sinn	10	Discontinued
Apr 16, 1981	AminophyllineANDA 87240	Luitpold	3	Discontinued
Aug 27, 1981	AminophyllineANDA 87600	Am Regent	19	Discontinued
Nov 10, 1981	AminophyllineANDA 87431	Lyphomed	2	Discontinued
Feb 1, 1982	AminophyllineANDA 87209	Intl Medication	5	Discontinued
Feb 9, 1982	AminophyllineANDA 87500	Roxane	8	Discontinued
Feb 9, 1982	AminophyllineANDA 87501	Roxane	8	Discontinued
Apr 16, 1982	Aminophylline Dye FreeANDA 87727	Actavis Mid Atlantic	17	Discontinued
May 24, 1982	AminophyllinANDA 87243	Gd Searle LLC	0	Discontinued
Jul 23, 1982	AminophyllineANDA 87601	Hospira	8	Discontinued
Jan 3, 1983	TruphyllineANDA 85498	Cosette Pharms Nc	9	Discontinued
Mar 31, 1983	AminophyllineANDA 88182	Duramed Pharms Barr	2	Discontinued
Mar 31, 1983	AminophyllineANDA 88183	Duramed Pharms Barr	2	Discontinued
May 3, 1983	Aminophylline In Sodium Chloride 0.45%ANDA 88147	Hospira	3	Discontinued
Aug 19, 1983	AminophyllineANDA 88297	Barr	0	Discontinued
Aug 19, 1983	AminophyllineANDA 88298	Barr	0	Discontinued
Aug 19, 1983	AminophyllineANDA 88126	Roxane	15	Discontinued
Oct 3, 1983	AminophyllineANDA 88314	Vangard	0	Discontinued
Oct 3, 1983	AminophyllineANDA 88319	Vangard	0	Discontinued
Oct 26, 1983	AminophyllineANDA 87242	Hospira	14	Marketed
Dec 15, 1983	AminophyllineANDA 87392	Pharma Serve Ny	0	Discontinued
Dec 12, 1984	Aminophylline In Sodium Chloride 0.45% In Plastic ContainerNDA 18924 · New formulation or manufacturer	Hospira	18	Discontinued
Sep 25, 1991	AminophyllineANDA 81142	Teva Parenteral	1	Discontinued
—	SomophyllinNDA 18232	Fisons	0	Discontinued
—	AminophyllineANDA 84574	Impax Labs	0	Discontinued
—	AminophyllineANDA 85333	Purepac Pharm	0	Discontinued
—	AminophyllineANDA 87886	Abraxis Pharm	0	Discontinued
—	AminophyllineANDA 84576	Impax Labs	0	Discontinued
—	AminophyllineANDA 84552	Panray	0	Discontinued
—	AminophyllineANDA 84530	Vale	0	Discontinued
—	AminophyllineANDA 84531	Vale	0	Discontinued
—	AminophyllineANDA 84533	Pal Pak	0	Discontinued
—	AminophyllineANDA 84568	Abraxis Pharm	0	Discontinued
—	AminophyllineANDA 84632	Tablicaps	0	Discontinued
—	AminophyllineANDA 84699	Purepac Pharm	0	Discontinued
—	AminophyllineANDA 85409	Vintage Pharms	0	Discontinued
—	AminophyllineANDA 85410	Vintage Pharms	0	Discontinued
—	AminophyllineANDA 85567	Watson Labs	5	Discontinued
—	SomophyllinANDA 86466	Fisons	0	Discontinued
—	AminophyllineANDA 86606	King Pharms	0	Discontinued
—	AminophyllineANDA 87200	Abraxis Pharm	0	Discontinued
—	AminophyllineANDA 87250	Abraxis Pharm	0	Discontinued
—	AminophyllineANDA 87387	Pharma Serve Ny	0	Discontinued
—	AminophyllineANDA 87522	Ascot	0	Discontinued
—	AminophyllineANDA 87523	Ascot	0	Discontinued
—	AminophyllinANDA 87621	Gd Searle LLC	0	Discontinued
—	AminophyllineANDA 87867	Intl Medication	0	Discontinued
—	AminophyllineANDA 87868	Intl Medication	0	Discontinued
—	AminophyllineANDA 88156	Morton Grove	0	Discontinued
—	AminophyllineANDA 88407	Abraxis Pharm	0	Discontinued
—	AminophyllineANDA 88429	Smith And Nephew	0	Discontinued
—	AminophyllineANDA 88749	Smith And Nephew	0	Discontinued
—	AminophyllineANDA 85564	Watson Labs	7	Discontinued

Show all 66

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA