DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021620
» See Plans and Pricing
NDA 021620 describes MUCINEX DM, which is a drug marketed by Rb Hlth and is included in one NDA. It is available from ten 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-three 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-three 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 | ATLANTIC BIOLOGICALS CORP. | 17856-0056 | 17856-0056-1 | 1 TABLET, EXTENDED RELEASE in 1 PACKAGE (17856-0056-1) |
| MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620 | NDA | Mechanical Servants LLC | 29485-6647 | 29485-6647-2 | 2 TABLET, EXTENDED RELEASE in 1 POUCH (29485-6647-2) |
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? | ||
Expired US Patents for NDA 021620
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-002 | Apr 29, 2004 | Start Trial | Start Trial |
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | Start Trial | Start Trial |
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
