Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Boehringer Ingelheim
Cantor Fitzgerald

Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011483

« Back to Dashboard

NDA 011483 describes SYNALGOS-DC, which is a drug marketed by Sun Pharm Industries and Leitner Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the SYNALGOS-DC profile page.

The generic ingredient in SYNALGOS-DC is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Summary for 011483
Applicant:Sun Pharm Industries
Ingredient:aspirin; caffeine; dihydrocodeine bitartrate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 011483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNALGOS-DC aspirin; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 011483 NDA Caraco Pharma Inc. 49708-419 N 49708-419-88
SYNALGOS-DC aspirin; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 011483 NDA AUTHORIZED GENERIC Caraco Pharmaceutical Laboratories, Ltd 57664-419 N 57664-419-88

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength356.4MG;30MG;16MG
Approval Date:Sep 6, 1983TE:RLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Federal Trade Commission
US Department of Justice

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.