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Details for New Drug Application (NDA): 021585
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The generic ingredient in MUCINEX D 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 021585
Tradename: | MUCINEX D |
Applicant: | Rb Hlth |
Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
Patents: | 3 |
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 |
Paragraph IV (Patent) Challenges for 021585
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MUCINEX D | TABLET, EXTENDED RELEASE;ORAL | guaifenesin; pseudoephedrine hydrochloride | 021585 | 2008-12-29 |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG;60MG | ||||
Approval Date: | Jun 22, 2004 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | EXPECTORANT AND NASAL DECONGESTANT | ||||||||
Patent: | Start Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021585
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