Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_OTC" table for query
on "021620."
| Active Ingredient: | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Dosage Form;Route: | TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: | MUCINEX DM |
| Applicant: | RECKITT BENCKISER |
| Strength: | 60MG;1.2GM |
| Application Number: | N021620 |
| Product Number: | 001 |
| Approval Date: | Apr 29, 2004 |
| Reference Listed Drug | Yes |
| RX/OTC/DISCN: | OTC |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Dosage Form;Route: | TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: | MUCINEX DM |
| Applicant: | RECKITT BENCKISER |
| Strength: | 30MG;600MG |
| Application Number: | N021620 |
| Product Number: | 002 |
| Approval Date: | Apr 29, 2004 |
| Reference Listed Drug | No |
| RX/OTC/DISCN: | OTC |
| Patent and Exclusivity Info for this product: | View |
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| FDA/Center for Drug Evaluation and Research |
| Office of Generic Drugs |
| Division of Labeling and Program Support |
| Update Frequency: |
| Orange Book Data - Monthly |
| Generic Drug Product Information & Patent Information - Daily |
| Orange Book Data Updated Through May, 2013 |
| Patent and Generic Drug Product Data Last Updated: June 18, 2013 |
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