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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-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. Thirty-two suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for NDA: 091586

Tris Pharma Inc
Therapeutic Class:Respiratory Tract Agents

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.