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Details for New Drug Application (NDA): 021620

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NDA 021620 describes MUCINEX DM, which is a drug marketed by Reckitt Benckiser and is included in one NDA. It is available from seven suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MUCINEX DM profile page.

The generic ingredient in MUCINEX DM is dextromethorphan hydrobromide; guaifenesin. There are twenty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for NDA: 021620

Tradename:
MUCINEX DM
Applicant:
Reckitt Benckiser
Ingredient:
dextromethorphan hydrobromide; guaifenesin
Patents:3
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021620

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL 021620 NDA ATLANTIC BIOLOGICALS CORP 17856-0056 17856-0056-1 1 TABLET, EXTENDED RELEASE in 1 PACKAGE (17856-0056-1)
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL 021620 NDA A-S Medication Solutions 54569-5986 54569-5986-0 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (54569-5986-0)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Apr 29, 2004TE:RLD:Yes
Patent:6,372,252Patent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,838,032Patent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,955,821Patent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:EXPECTORANT AND COUGH SUPPRESSANT


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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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