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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 085261

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NDA 085261 describes AMINOPHYLLINE, which is a drug marketed by Abraxis Pharm, Am Regent, Elkins Sinn, Hospira, Intl Medication, King Pharms, Luitpold, Lyphomed, Pharma Serve Ny, Smith And Nephew, Teva Parenteral, Morton Grove, Roxane, Impax Labs, Tablicaps, Vale, Ani Pharms, Ascot, Barr, Chartwell Molecular, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, Pal Pak, Panray, Purepac Pharm, Valeant Pharm Intl, Vangard, Vintage Pharms, Watson Labs, and Actavis Mid Atlantic, and is included in fifty-eight NDAs. It is available from five suppliers. Additional details are available on the AMINOPHYLLINE profile page.

The generic ingredient in AMINOPHYLLINE is aminophylline. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aminophylline profile page.

Summary for 085261

Tradename:	AMINOPHYLLINE
Applicant:	Ani Pharms
Ingredient:	aminophylline
Patents:	0

Medical Subject Heading (MeSH) Categories for 085261

Bronchodilator Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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