➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

Last Updated: July 9, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091586

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 091586 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, Lannett Co Inc, Tris Pharma Inc, Able, Alembic Pharms Ltd, Glenmark Generics, Heritage Pharma, Nostrum Labs Inc, Rhodes Pharms, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in forty-three NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 091586
Applicant:Tris Pharma Inc
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
THEOPHYLLINE theophylline SOLUTION;ORAL 091586 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0038 17856-0038-1 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) > 15 mL in 1 CUP, UNIT-DOSE
THEOPHYLLINE theophylline SOLUTION;ORAL 091586 ANDA Tris Pharma Inc 27808-033 27808-033-01 473 mL in 1 BOTTLE (27808-033-01)

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School

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 verification 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.