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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040086


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NDA 040086 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 Generics, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Leading, Nostrum Labs Inc, Rhodes Pharms, Teva Pharms Inc, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in fifty-one NDAs. It is available from nineteen 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 suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 040086
Tradename:THEOPHYLLINE
Applicant:Rhodes Pharms
Ingredient:theophylline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040086
Suppliers and Packaging for NDA: 040086
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040086 ANDA Rhodes Pharmaceuticals L.P. 42858-701 42858-701-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Apr 15, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Sep 1, 1982TE:ABRLD:Yes

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