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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 218401

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NDA 218401 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 218401

Tradename:	THEOPHYLLINE
Applicant:	Ajanta Pharma Ltd
Ingredient:	theophylline
Patents:	0

Pharmacology for NDA: 218401

Medical Subject Heading (MeSH) Categories for 218401

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 218401

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	218401	ANDA	Ajanta Pharma USA Inc.	27241-272	27241-272-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-272-01)
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	218401	ANDA	Ajanta Pharma USA Inc.	27241-273	27241-273-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-273-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	450MG
Approval Date:	Jan 13, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Mar 26, 2025	TE:		RLD:	No

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