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Generated: June 16, 2019

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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 six 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. Thirty-four 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
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 17856-0172-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) > 10 mL in 1 CUP, UNIT-DOSE
DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658 NDA Atlantic Biologicals Corps 17856-0276 17856-0276-1 10 mL in 1 CUP (17856-0276-1)

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

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