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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 018658


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NDA 018658 describes DELSYM, which is a drug marketed by Rb Hlth and is included in one NDA. It is available from two 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-six 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 A-S Medication Solutions 50090-0224 50090-0224-0 1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE
DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658 NDA RB Health (US) LLC 63824-171 63824-171-22 2 CARTON in 1 CELLO PACK (63824-171-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE

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 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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