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Details for New Drug Application (NDA): 021620
NDA 021620 describes MUCINEX DM, which is a drug marketed by Reckitt Benckiser and is included in one NDA. It is available from fourteen suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MUCINEX DM profile page.
The generic ingredient in MUCINEX DM is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
The generic ingredient in MUCINEX DM is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021620
| Tradename: | MUCINEX DM |
| Applicant: | Reckitt Benckiser |
| Ingredient: | dextromethorphan hydrobromide; guaifenesin |
| Patents: | 3 |
Suppliers and Packaging for NDA: 021620
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620 | NDA | walgreens | 0363-0076 | 0363-0076-14 | 1 BLISTER PACK in 1 CARTON (0363-0076-14) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620 | NDA | walgreens | 0363-0076 | 0363-0076-28 | 2 BLISTER PACK in 1 CARTON (0363-0076-28) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG;1.2GM | ||||
| Approval Date: | Apr 29, 2004 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | EXPECTORANT AND COUGH SUPPRESSANT | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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