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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 216961

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NDA 216961 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 216961

Tradename:	THEOPHYLLINE
Applicant:	Teva Pharms Inc
Ingredient:	theophylline
Patents:	0

Pharmacology for NDA: 216961

Medical Subject Heading (MeSH) Categories for 216961

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 216961

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	216961	ANDA	Teva Pharmaceuticals, Inc.	0480-3309	0480-3309-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3309-01)
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	216961	ANDA	Teva Pharmaceuticals, Inc.	0480-3310	0480-3310-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3310-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Oct 12, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	450MG
Approval Date:	Oct 12, 2022	TE:	AB	RLD:	No

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