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Generated: May 1, 2017

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Details for New Drug Application (NDA): 091586

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NDA 091586 describes THEOPHYLLINE, which is a drug marketed by Alpharma Us Pharms, Pliva, Pharm Assoc, Taro, Alembic Ltd, Scherer Rp, Hospira, Inwood Labs, Teva Pharms, Roxane, Able, Wockhardt, Perrigo, Cent Pharms, Glenmark Generics, Silarx, Mylan Ireland Ltd, Sandoz, Kv Pharm, Precision Dose, Halsey, Rhodes Pharms, Cenci, Tris Pharma Inc, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in forty-four NDAs. It is available from twenty-four 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. Thirty suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for NDA: 091586

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091586


Suppliers and Packaging for NDA: 091586

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 091586 ANDA Tris Pharma Inc 27808-033 27808-033-01 473 mL in 1 BOTTLE (27808-033-01)
SOLUTION;ORAL 091586 ANDA Cranbury Pharmaceuticals Inc 60621-033 60621-033-01 473 mL in 1 BOTTLE (60621-033-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength80MG/15ML
Approval Date:Jun 15, 2012TE:AARLD:No

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