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 three 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

Pharmacology for NDA: 018658

Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 018658

Antitussive Agents
Excitatory Amino Acid Antagonists

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:	OTC	Dosage:	SUSPENSION, EXTENDED RELEASE;ORAL			Strength	EQ 30MG HYDROBROMIDE/5ML
Approval Date:	Oct 8, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018658

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

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