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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 215312

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NDA 215312 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 215312

Tradename:	THEOPHYLLINE
Applicant:	Strides Pharma
Ingredient:	theophylline
Patents:	0

Pharmacology for NDA: 215312

Medical Subject Heading (MeSH) Categories for 215312

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 215312

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	215312	ANDA	Strides Pharma Science Limited	64380-243	64380-243-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-243-01)
THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	215312	ANDA	Strides Pharma Science Limited	64380-244	64380-244-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-244-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Sep 5, 2024	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Mar 26, 2025
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	450MG
Approval Date:	Sep 5, 2024	TE:	AB	RLD:	No

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