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Details for New Drug Application (NDA): 021620
NDA 021620 describes MUCINEX DM, which is a drug marketed by Rb Hlth and is included in one NDA. It is available from twelve 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. Fifty-four 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. Fifty-four suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021620
| Tradename: | MUCINEX DM |
| Applicant: | Rb Hlth |
| 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 |
Paragraph IV (Patent) Challenges for 021620
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MUCINEX DM | TABLET, EXTENDED RELEASE;ORAL | dextromethorphan hydrobromide; guaifenesin | 021620 | 2008-12-17 |
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: | 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 COUGH SUPPRESSANT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 28, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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