Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "019892."
| Active Ingredient: | HYDROMORPHONE HYDROCHLORIDE |
| Dosage Form;Route: | TABLET; ORAL |
| Proprietary Name: | DILAUDID |
| Applicant: | PURDUE PHARM PRODS |
| Strength: | 8MG |
| Application Number: | N019892 |
| Product Number: | 001 |
| Approval Date: | Dec 7, 1992 |
| 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: | HYDROMORPHONE HYDROCHLORIDE |
| Dosage Form;Route: | TABLET; ORAL |
| Proprietary Name: | DILAUDID |
| Applicant: | PURDUE PHARM PRODS |
| Strength: | 4MG |
| Application Number: | N019892 |
| Product Number: | 002 |
| Approval Date: | Nov 9, 2007 |
| 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: | HYDROMORPHONE HYDROCHLORIDE |
| Dosage Form;Route: | TABLET; ORAL |
| Proprietary Name: | DILAUDID |
| Applicant: | PURDUE PHARM PRODS |
| Strength: | 2MG |
| Application Number: | N019892 |
| Product Number: | 003 |
| Approval Date: | Nov 9, 2007 |
| 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 May, 2013 |
| Patent and Generic Drug Product Data Last Updated: June 19, 2013 |
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