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Generated: July 20, 2017

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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 four 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-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for NDA: 021585

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

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 Physicians Total Care, Inc. 54868-5849 54868-5849-0 2 BLISTER PACK in 1 CARTON (54868-5849-0) > 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021585 NDA Reckitt Benckiser LLC 63824-041 63824-041-24 2 BLISTER PACK in 1 CARTON (63824-041-24) > 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:Jun 22, 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 NASAL DECONGESTANT


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Serving 500+ biopharmaceutical companies globally:

Colorcon
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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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