Application 208379
- Type
- NDA
- Sponsor
- MEDICURE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | TABLET;ORAL | EQ 1MG BASE | Yes | No |
| 002 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | TABLET;ORAL | EQ 2MG BASE | Yes | No |
| 003 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | TABLET;ORAL | EQ 4MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208379-001 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | |
| N208379-002 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | |
| N208379-003 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | |
| N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | |
| N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 |
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 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 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 |
|---|---|---|---|---|---|---|
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | Medicure International Inc | c8c50e03-5cb8-43f4-bdef-8edd12f1945f | 2025-12-03 | Warnings, Adverse reactions | 208379 NDA208379 25208-201 25208-202 |
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | Zydus Lifesciences Limited | e9f0fe3a-0462-4c24-8f22-3c89afe8fcea | 2024-08-14 | 208379 NDA208379 70771-1117 70771-1118 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25208-200 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-200 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-200 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-201 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-201 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-201 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-201 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-201 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-202 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-202 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-202 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-202 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 25208-202 | ZYPITAMAG | Pitavastatin Magnesium | Medicure International Inc | NDA | Current |
| 70771-1116 | ZYPITAMAG | Pitavastatin Magnesium | Cadila Healthcare Limited | NDA | Current |
| 70771-1117 | ZYPITAMAG | Pitavastatin Magnesium | Cadila Healthcare Limited | NDA | Current |
| 70771-1117 | ZYPITAMAG | Pitavastatin Magnesium | Cadila Healthcare Limited | NDA | Current |
| 70771-1117 | ZYPITAMAG | Pitavastatin Magnesium | Zydus Lifesciences Limited | NDA | Current |
| 70771-1118 | ZYPITAMAG | Pitavastatin Magnesium | Cadila Healthcare Limited | NDA | Current |
| 70771-1118 | ZYPITAMAG | Pitavastatin Magnesium | Cadila Healthcare Limited | NDA | Current |
| 70771-1118 | ZYPITAMAG | Pitavastatin Magnesium | Zydus Lifesciences Limited | NDA | Current |