Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "022246."
| Active Ingredient: | METOCLOPRAMIDE HYDROCHLORIDE |
| Dosage Form;Route: | TABLET, ORALLY DISINTEGRATING; ORAL |
| Proprietary Name: | METOZOLV ODT |
| Applicant: | SALIX PHARMS |
| Strength: | EQ 5MG BASE |
| Application Number: | N022246 |
| Product Number: | 001 |
| Approval Date: | Sep 4, 2009 |
| Reference Listed Drug | No |
| RX/OTC/DISCN: | RX |
| TE Code: | |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | METOCLOPRAMIDE HYDROCHLORIDE |
| Dosage Form;Route: | TABLET, ORALLY DISINTEGRATING; ORAL |
| Proprietary Name: | METOZOLV ODT |
| Applicant: | SALIX PHARMS |
| Strength: | EQ 10MG BASE |
| Application Number: | N022246 |
| Product Number: | 002 |
| Approval Date: | Sep 4, 2009 |
| Reference Listed Drug | Yes |
| RX/OTC/DISCN: | RX |
| TE Code: | |
| 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 21, 2013 |
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