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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216300

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NDA 216300 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for 216300

Tradename:	THEOPHYLLINE
Applicant:	Bionpharma
Ingredient:	theophylline
Patents:	0

Pharmacology for NDA: 216300

Medical Subject Heading (MeSH) Categories for 216300

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 216300

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	216300	ANDA	Bionpharma Inc.,	69452-267	69452-267-20	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69452-267-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Apr 26, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	450MG
Approval Date:	Apr 26, 2023	TE:	AB	RLD:	No

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