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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 091586

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NDA 091586 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 091586

Tradename:	THEOPHYLLINE
Applicant:	Tris Pharma Inc
Ingredient:	theophylline
Patents:	0

Pharmacology for NDA: 091586

Medical Subject Heading (MeSH) Categories for 091586

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 091586

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	SOLUTION;ORAL	091586	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0038	17856-0038-1	50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) / 15 mL in 1 CUP, UNIT-DOSE
THEOPHYLLINE	theophylline	SOLUTION;ORAL	091586	ANDA	Tris Pharma Inc	27808-033	27808-033-01	473 mL in 1 BOTTLE (27808-033-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	80MG/15ML
Approval Date:	Jun 15, 2012	TE:	AA	RLD:	No

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