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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 Rb Hlth and is included in two NDAs. It is available from six 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. Fifty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
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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