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Details for New Drug Application (NDA): 020741
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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DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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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