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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. It is available from one supplier. 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 |
Pharmacology for NDA: 020741
| Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 020741
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRANDIN | repaglinide | TABLET;ORAL | 020741 | NDA | Novo Nordisk | 0169-0081 | 0169-0081-80 | 12 TABLET in 1 BOTTLE, PLASTIC (0169-0081-80) |
| PRANDIN | repaglinide | TABLET;ORAL | 020741 | NDA | Novo Nordisk | 0169-0081 | 0169-0081-81 | 100 TABLET in 1 BOTTLE, PLASTIC (0169-0081-81) |
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 | ||||
| Approval Date: | Dec 22, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 22, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| 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 | 020741-003 | 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 | 020741-003 | Dec 22, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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