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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 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. Forty-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. Forty-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: | Reckitt Benckiser |
| Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
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 | A-S Medication Solutions | 50090-1075 | N | 50090-1075-0 |
| MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585 | NDA | A-S Medication Solutions | 50090-1076 | N | 50090-1076-0 |
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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