Application 021060

Type: NDA
Sponsor: TERSERA THERAPS LLC

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	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.

Product history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 700 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRIALT	ZICONOTIDE ACETATE	TerSera Therapeutics LLC	b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1	2025-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021060 application number: NDA021060 ndc (product): 70720-720 ndc (product): 70720-723 ndc (product): 70720-722

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74178	SUPPL	2023-05-04
26606	SUPPL	2011-09-06
14261	SUPPL	2011-09-02
41916	SUPPL	2007-07-20
26605	SUPPL	2007-04-25
14260	SUPPL	2007-04-20
26604	SUPPL	2005-05-27
21400	ORIG	2005-04-27
35991	ORIG	2004-12-29
4181	ORIG	2004-12-29