Application 020741
- Type
- NDA
- Sponsor
- GEMINI LABS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRANDIN | REPAGLINIDE | TABLET;ORAL | 0.5MG | Yes | No |
| 002 | PRANDIN | REPAGLINIDE | TABLET;ORAL | 1MG | Yes | No |
| 003 | PRANDIN | REPAGLINIDE | TABLET;ORAL | 2MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020741-001 | PRANDIN | REPAGLINIDE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | |
| N020741-002 | PRANDIN | REPAGLINIDE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | |
| N020741-003 | PRANDIN | REPAGLINIDE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020741-002 | PRANDIN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020741-003 | PRANDIN | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020741-001 | PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-12-22 | 8072bd15b7f6… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Repaglinide | REPAGLINIDE | Bryant Ranch Prepack | 6ae28683-28cc-408e-90f9-6a3dddfc668d | 2025-11-04 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | NorthStar RxLLC | 7f3118ce-fcbb-4f8b-b1ba-d8cd95e5b665 | 2025-09-15 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Bryant Ranch Prepack | d85abce4-16da-4231-b28a-6afca04ebf68 | 2025-06-05 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Chartwell RX, LLC | cb995e92-295e-4638-a064-978211f5afe1 | 2025-05-02 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Bryant Ranch Prepack | 9f2006d9-e0c0-4cc4-b2c9-84b7d9f77173 | 2025-01-23 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Bryant Ranch Prepack | 3b150917-e2fd-4366-af83-ebc1d7297ca9 | 2025-01-16 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | American Health Packaging | dd1d8337-9903-4b8a-a9ea-569e4d134e74 | 2024-10-22 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Aurobindo Pharma Limited | 68064989-47ea-4ed5-a20e-43c4ef6ec271 | 2024-05-14 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Rising Pharma Holdings, Inc. | d7673e22-0dbb-4395-ad60-943d249203a1 | 2024-05-14 | Warnings, Adverse reactions | REPAGLINIDE |
| Repaglinide | REPAGLINIDE | Macleods Pharmaceuticals Limited | 7a93246c-9323-40c4-b590-a40dcb133c8c | 2023-04-04 | Warnings, Adverse reactions | REPAGLINIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-0081 | Prandin | repaglinide | Novo Nordisk | NDA | Current |
| 0169-0082 | Prandin | repaglinide | Novo Nordisk | NDA | Current |
| 0169-0084 | Prandin | repaglinide | Novo Nordisk | NDA | Current |
| 68151-3565 | Prandin | repaglinide | Carilion Materials Management | NDA | Current |
| 68151-3566 | Prandin | repaglinide | Carilion Materials Management | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57515 | SUPPL | 2019-02-13 |
| 57327 | SUPPL | 2019-01-23 |
| 57326 | ORIG | 2019-01-23 |
| 47153 | SUPPL | 2017-02-09 |
| 47152 | SUPPL | 2017-02-09 |
| 47145 | SUPPL | 2017-02-09 |
| 47144 | SUPPL | 2017-02-09 |
| 13325 | SUPPL | 2012-03-06 |
| 3244 | SUPPL | 2012-03-05 |
| 3243 | SUPPL | 2010-08-03 |
| 13324 | SUPPL | 2010-07-31 |
| 35253 | SUPPL | 2009-06-22 |
| 3242 | SUPPL | 2009-06-16 |
| 13323 | SUPPL | 2008-07-15 |
| 3241 | SUPPL | 2008-07-15 |
| 41637 | SUPPL | 2007-07-06 |
| 41636 | SUPPL | 2007-07-06 |
| 41635 | SUPPL | 2007-07-06 |
| 20893 | SUPPL | 2007-07-06 |
| 20892 | SUPPL | 2007-07-06 |
| 3240 | SUPPL | 2006-06-28 |
| 13322 | SUPPL | 2005-02-11 |
| 3239 | SUPPL | 2005-02-11 |
| 3238 | SUPPL | 2003-10-17 |
| 25668 | SUPPL | 2003-08-29 |
| 13321 | SUPPL | 2003-08-29 |
| 25667 | SUPPL | 2002-10-21 |
| 13320 | SUPPL | 2002-10-21 |
| 13319 | SUPPL | 2002-01-18 |
| 3237 | SUPPL | 2002-01-18 |