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Generated: May 1, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018658

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NDA 018658 describes DELSYM, which is a drug marketed by Reckitt Benckiser and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DELSYM profile page.

The generic ingredient in DELSYM is dextromethorphan polistirex. There are twenty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.

Summary for NDA: 018658

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

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 Corps 17856-0276 17856-0276-1 10 mL in 1 CUP (17856-0276-1)
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 018658 NDA Rebel Distributors Corp 21695-517 21695-517-30 90 mL in 1 BOTTLE (21695-517-30)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 30MG HBR/5ML
Approval Date:Oct 8, 1982TE:RLD:Yes
Patent:5,980,882Patent Expiration:Apr 16, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 018658

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Reckitt Benckiser
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL018658-001Oct 8, 19824,221,778► Subscribe
Reckitt Benckiser
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL018658-001Oct 8, 19825,980,882► Subscribe
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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.

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