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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 218063

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NDA 218063 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, 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-three NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for 218063

Tradename:	THEOPHYLLINE
Applicant:	Zydus Lifesciences
Ingredient:	theophylline
Patents:	0

Pharmacology for NDA: 218063

Medical Subject Heading (MeSH) Categories for 218063

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 218063

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	218063	ANDA	Zydus Lifesciences Limited	70771-1782	70771-1782-1	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1782-1)
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	218063	ANDA	Zydus Lifesciences Limited	70771-1783	70771-1783-1	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1783-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	May 21, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	450MG
Approval Date:	May 21, 2024	TE:	AB	RLD:	No

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