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Last Updated: May 29, 2024

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 seven 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. Sixty-two 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
Pharmacology for NDA: 021282
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 A-S Medication Solutions 50090-0818 50090-0818-0 2 BLISTER PACK in 1 CARTON (50090-0818-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282 NDA A-S Medication Solutions 50090-1340 50090-1340-0 1 BLISTER PACK in 1 CARTON (50090-1340-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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

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