Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "020387."
| Active Ingredient: | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
| Dosage Form;Route: | TABLET; ORAL |
| Proprietary Name: | HYZAAR |
| Applicant: | MERCK |
| Strength: | 12.5MG;50MG |
| Application Number: | N020387 |
| Product Number: | 001 |
| Approval Date: | Apr 28, 1995 |
| Reference Listed Drug | No |
| RX/OTC/DISCN: | RX |
| TE Code: | AB |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
| Dosage Form;Route: | TABLET; ORAL |
| Proprietary Name: | HYZAAR |
| Applicant: | MERCK |
| Strength: | 25MG;100MG |
| Application Number: | N020387 |
| Product Number: | 002 |
| Approval Date: | Nov 10, 1998 |
| Reference Listed Drug | Yes |
| RX/OTC/DISCN: | RX |
| TE Code: | AB |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
| Dosage Form;Route: | TABLET; ORAL |
| Proprietary Name: | HYZAAR |
| Applicant: | MERCK |
| Strength: | 12.5MG;100MG |
| Application Number: | N020387 |
| Product Number: | 003 |
| Approval Date: | Oct 20, 2005 |
| Reference Listed Drug | No |
| RX/OTC/DISCN: | RX |
| TE Code: | AB |
| 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 23, 2013 |
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