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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 040052

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NDA 040052 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 040052

Tradename:	THEOPHYLLINE
Applicant:	Inwood Labs
Ingredient:	theophylline
Patents:	0

Medical Subject Heading (MeSH) Categories for 040052

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Feb 14, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	125MG
Approval Date:	Feb 14, 1994	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Feb 14, 1994	TE:		RLD:	No

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