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Details for New Drug Application (NDA): 021585
NDA 021585 describes MUCINEX D, which is a drug marketed by Reckitt Benckiser and is included in two NDAs. It is available from eight 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. Forty-eight 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. Forty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021585
| Tradename: | MUCINEX D |
| Applicant: | Reckitt Benckiser |
| Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 021585
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 021585
| Mechanism of Action | Adrenergic 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 | WALGREEN COMPANY | 0363-0077 | N | 0363-0077-18 |
| MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585 | NDA | WALGREEN COMPANY | 0363-0077 | N | 0363-0077-36 |
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: | ➤ Sign Up | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | EXPECTORANT AND NASAL DECONGESTANT | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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