Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Dow
McKesson
AstraZeneca
McKinsey

Last Updated: October 6, 2022

Details for New Drug Application (NDA): 018658


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 018658 describes DELSYM, which is a drug marketed by Rb Hlth and is included in one NDA. It is available from four suppliers. Additional details are available on the DELSYM profile page.

The generic ingredient in DELSYM is dextromethorphan polistirex. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
Summary for 018658
Tradename:DELSYM
Applicant:Rb Hlth
Ingredient:dextromethorphan polistirex
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018658
Medical Subject Heading (MeSH) Categories for 018658
Suppliers and Packaging for NDA: 018658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658 NDA ATLANTIC BIOLOGICALS CORP. 17856-0172 17856-0172-3 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-2) > 5 mL in 1 CUP, UNIT-DOSE
DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658 NDA ATLANTIC BIOLOGICALS CORP. 17856-0172 17856-0172-4 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-4) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) > 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 30MG HYDROBROMIDE/5ML
Approval Date:Oct 8, 1982TE:RLD:Yes

Expired US Patents for NDA 018658

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 See Plans and Pricing See Plans and Pricing
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Boehringer Ingelheim
Dow
Baxter
McKesson

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.