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Last Updated: March 2, 2021

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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 Rb Hlth and is included in one NDA. It is available from ten 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-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021620
Tradename:MUCINEX DM
Applicant:Rb Hlth
Ingredient:dextromethorphan hydrobromide; guaifenesin
Patents:3
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 Mechanical Servants LLC 29485-6647 29485-6647-2 2 TABLET, EXTENDED RELEASE in 1 POUCH (29485-6647-2)
Paragraph IV (Patent) Challenges for 021620
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX DM TABLET, EXTENDED RELEASE;ORAL dextromethorphan hydrobromide; guaifenesin 021620 2008-12-17

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Apr 29, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:EXPECTORANT AND COUGH SUPPRESSANT
Patent:  Start TrialPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021620

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004   Start Trial   Start Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004   Start Trial   Start Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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