Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_OTC" table for query
on "021128."
| Active Ingredient: | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Dosage Form;Route: | SUSPENSION; ORAL |
| Proprietary Name: | CHILDREN'S MOTRIN COLD |
| Applicant: | MCNEIL CONS |
| Strength: | 100MG/5ML;15MG/5ML |
| Application Number: | N021128 |
| Product Number: | 001 |
| Approval Date: | Aug 1, 2000 |
| Reference Listed Drug | Yes |
| 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 April, 2013 |
| Patent and Generic Drug Product Data Last Updated: May 20, 2013 |
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