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Generated: September 23, 2018

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Details for New Drug Application (NDA): 021585

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NDA 021585 describes MUCINEX D, which is a drug marketed by Reckitt Benckiser and is included in two NDAs. 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 D profile page.

The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021585
Pharmacology for NDA: 021585
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 021585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585 NDA WALGREEN COMPANY 0363-0077 0363-0077-18 1 BLISTER PACK in 1 CARTON (0363-0077-18) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585 NDA WALGREEN COMPANY 0363-0077 0363-0077-36 2 BLISTER PACK in 1 CARTON (0363-0077-36) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:Jun 22, 2004TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:EXPECTORANT AND NASAL DECONGESTANT
Patent:➤ Sign UpPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?

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