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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 085263

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NDA 085263 describes THEOPHYLLINE, which is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Sun Pharma Canada, Wockhardt, Chartwell Molecular, Tris Pharma Inc, Able, Ajanta Pharma Ltd, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Mpp Pharma, Nostrum Pharms Llc, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in fifty-five NDAs. It is available from twenty-eight suppliers. Additional details are available on the THEOPHYLLINE profile page.

The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for 085263

Tradename:	THEOPHYLLINE
Applicant:	Kv Pharm
Ingredient:	theophylline
Patents:	0

Medical Subject Heading (MeSH) Categories for 085263

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Profile for product number 001

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

Profile for product number 002

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

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