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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214806


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NDA 214806 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 214806
Tradename:THEOPHYLLINE
Applicant:Harman Finochem
Ingredient:theophylline
Patents:0
Pharmacology for NDA: 214806
Suppliers and Packaging for NDA: 214806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 214806 ANDA Sun Pharmaceutical Industries Limited 70095-017 70095-017-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01)
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 214806 ANDA Sun Pharmaceutical Industries Limited 70095-018 70095-018-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-018-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Oct 24, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength450MG
Approval Date:Oct 24, 2023TE:ABRLD:No

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