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Details for New Drug Application (NDA): 021620
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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 |
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