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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 090430


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NDA 090430 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 090430
Tradename:THEOPHYLLINE
Applicant:Alembic
Ingredient:theophylline
Patents:0
Pharmacology for NDA: 090430
Suppliers and Packaging for NDA: 090430
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090430 ANDA Alembic Pharmaceuticals Limited 46708-025 46708-025-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-30)
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090430 ANDA Alembic Pharmaceuticals Limited 46708-025 46708-025-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Oct 27, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength450MG
Approval Date:Oct 27, 2010TE:ABRLD:No

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