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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 086506

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NDA 086506 describes THEOPHYL, which is a drug marketed by Ortho Mcneil Pharm, Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, Chartwell Molecular, Tris Pharma Inc, Able, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Nostrum Labs Inc, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in fifty-eight NDAs. Additional details are available on the THEOPHYL profile page.

The generic ingredient in THEOPHYL is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for 086506

Tradename:	THEOPHYL
Applicant:	Ortho Mcneil Pharm
Ingredient:	theophylline
Patents:	0

Medical Subject Heading (MeSH) Categories for 086506

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	100MG
Approval Date:	Sep 12, 1985	TE:		RLD:	No

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