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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 206344

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NDA 206344 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 206344

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

Pharmacology for NDA: 206344

Medical Subject Heading (MeSH) Categories for 206344

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 206344

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	SOLUTION, ELIXIR;ORAL	206344	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0820	0121-0820-04	118 mL in 1 BOTTLE (0121-0820-04)
THEOPHYLLINE	theophylline	SOLUTION, ELIXIR;ORAL	206344	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0820	0121-0820-16	473 mL in 1 BOTTLE (0121-0820-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, ELIXIR;ORAL			Strength	80MG/15ML
Approval Date:	Dec 16, 2016	TE:	AA	RLD:	No

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