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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 090355


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NDA 090355 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 090355
Tradename:THEOPHYLLINE
Applicant:Glenmark Pharms Ltd
Ingredient:theophylline
Patents:0
Pharmacology for NDA: 090355
Suppliers and Packaging for NDA: 090355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090355 ANDA Glenmark Pharmaceuticals Inc., USA 68462-356 68462-356-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-01)
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090355 ANDA Glenmark Pharmaceuticals Inc., USA 68462-356 68462-356-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Jul 13, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Jul 13, 2010TE:ABRLD:No

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