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Last Updated: July 29, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021282


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NDA 021282 describes MUCINEX, which is a drug marketed by Rb Hlth and is included in three NDAs. It is available from seventeen suppliers. Additional details are available on the MUCINEX profile page.

The generic ingredient in MUCINEX 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 021282
Tradename:MUCINEX
Applicant:Rb Hlth
Ingredient:guaifenesin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021282
Suppliers and Packaging for NDA: 021282
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282 NDA Atlantic Biologicals Corps 17856-0008 17856-0008-2 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2)
MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282 NDA KROGER COMPANY 30142-701 30142-701-20 1 BLISTER PACK in 1 CARTON (30142-701-20) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021282
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX TABLET, EXTENDED RELEASE;ORAL guaifenesin 021282 2006-06-09

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Jul 12, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Dec 18, 2002TE:RLD:Yes

Expired US Patents for NDA 021282

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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