Application 021060
- Type
- NDA
- Sponsor
- TERSERA THERAPS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRIALT | ZICONOTIDE ACETATE | INJECTABLE;INTRATHECAL | 500MCG/20ML (25MCG/ML) | Yes | Yes |
| 002 | PRIALT | ZICONOTIDE ACETATE | INJECTABLE;INTRATHECAL | 100MCG/1ML (100MCG/ML) | Yes | Yes |
| 003 | PRIALT | ZICONOTIDE ACETATE | INJECTABLE;INTRATHECAL | 200MCG/2ML (100MCG/ML) | No | No |
| 004 | PRIALT | ZICONOTIDE ACETATE | INJECTABLE;INTRATHECAL | 500MCG/5ML (100MCG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021060-001 | PRIALT | ZICONOTIDE ACETATE | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | |
| N021060-002 | PRIALT | ZICONOTIDE ACETATE | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | |
| N021060-003 | PRIALT | ZICONOTIDE ACETATE | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | ||
| N021060-004 | PRIALT | ZICONOTIDE ACETATE | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 |
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 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| PRIALT | ZICONOTIDE ACETATE | ESTEVE PHARMACEUTICALS, S.A. | 57376a5b-4530-9018-e063-6394a90a9afe | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 021060 NDA021060 |
| PRIALT | ZICONOTIDE ACETATE | TerSera Therapeutics LLC | b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1 | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | 021060 NDA021060 70720-720 70720-723 70720-722 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 18860-720 | Prialt | ziconotide | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-722 | Prialt | ziconotide | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-723 | Prialt | ziconotide | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 70720-720 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-720 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-720 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-722 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-722 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-722 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-723 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-723 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |
| 70720-723 | PRIALT | ziconotide acetate | TerSera Therapeutics LLC | NDA | Current |