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Details for New Drug Application (NDA): 020741
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NDA 020741 describes PRANDIN, which is a drug marketed by Gemini Labs Llc and is included in one NDA. Additional details are available on the PRANDIN profile page.
The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the repaglinide profile page.
The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the repaglinide profile page.
Summary for 020741
| Tradename: | PRANDIN |
| Applicant: | Gemini Labs Llc |
| Ingredient: | repaglinide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Paragraph IV (Patent) Challenges for 020741
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PRANDIN | TABLET;ORAL | repaglinide | 020741 | 2005-02-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Dec 22, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Dec 22, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Dec 22, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020741
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | Start Trial | Start Trial |
| Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-002 | Dec 22, 1997 | Start Trial | Start Trial |
| Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-002 | Dec 22, 1997 | Start Trial | Start Trial |
| Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-001 | Dec 22, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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