Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

Farmers Insurance
US Army
Boehringer Ingelheim

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088864

« Back to Dashboard

NDA 088864 describes PROMETHAZINE W/ DEXTROMETHORPHAN, which is a drug marketed by Wockhardt and is included in one NDA. It is available from four suppliers. Additional details are available on the PROMETHAZINE W/ DEXTROMETHORPHAN profile page.

The generic ingredient in PROMETHAZINE W/ DEXTROMETHORPHAN is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

Summary for 088864

Formulation / Manufacturing:see details

Pharmacology for NDA: 088864

Suppliers and Packaging for NDA: 088864

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE W/ DEXTROMETHORPHAN dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088864 ANDA Atlantic Biologicals Corps 17856-0604 17856-0604-5 5 mL in 1 CUP (17856-0604-5)
PROMETHAZINE W/ DEXTROMETHORPHAN dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088864 ANDA Rebel Distributors Corp 21695-698 21695-698-04 118 mL in 1 BOTTLE (21695-698-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Jan 4, 1985TE:AARLD:No

Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Queensland Health
Argus Health

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch: