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Last Updated: November 24, 2024

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 five suppliers. 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. Sixty-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:0
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 50090-1077 50090-1077-0 1 BLISTER PACK in 1 CARTON (50090-1077-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Apr 29, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG;600MG
Approval Date:Apr 29, 2004TE:RLD:Yes

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

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