Application 022408

Type: NDA
Sponsor: PARAPRO LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NATROBA	SPINOSAD	SUSPENSION;TOPICAL	0.9%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022408-001	NATROBA	SPINOSAD	0.9%	SUSPENSION / TOPICAL		RLD, RS	2011-01-18

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022408-001	9895388	2033-11-25	U-3365		2022-05-19

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022408-001	6342482	2019-06-22	U-1105	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022408-001	7030095	2021-07-02	U-1105	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022408-001	7030095	2021-07-02	U-1105	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022408-001	7030095	2021-07-02	U-1105	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022408-001	6342482	2019-06-22	U-1105	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022408-001	6342482	2019-06-22	U-1105	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022408-001	7030095	2021-07-02	U-1105	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022408-001	6342482	2019-06-22	U-1105	Drug product		`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022408-001	I-858	2024-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022408-001	I-858	2024-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022408-001	I-858	2024-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022408-001	I-858	2024-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022408-001	I-858	2024-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022408-001	I-858	2024-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022408-001	I-858	2024-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022408-001	I-858	2024-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022408-001	I-858	2024-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	I-858	2024-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022408-001	I-858	2024-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022408-001	I-858	2024-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022408-001	I-858	2024-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022408-001	I-858	2024-04-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022408-001	I-858	2024-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022408-001	I-858	2024-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022408-001	I-858	2024-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022408-001	I-858	2024-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022408-001	I-858	2024-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022408-001	I-858	2024-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022408-001	I-858	2024-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022408-001	I-858	2024-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022408-001	I-858	2024-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022408-001	I-858	2024-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022408-001	I-858	2024-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022408-001	I-858	2024-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022408-001	I-858	2024-04-28	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spinosad	SPINOSAD	Cipher Pharmaceuticals Inc.	16a95039-0df7-45d5-8b51-bbc81443fea3	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408
Natroba	SPINOSAD	Cipher Pharmaceuticals Inc.	72cf38f4-9ef4-4b0e-b085-b02f399e2592	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408
Spinosad	SPINOSAD	Allegis Pharmaceuticals, LLC	8e87bd3b-db25-4e97-bf57-96c875f67ce1	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408 ndc (product): 28595-570
Spinosad	SPINOSAD	ParaPRO LLC	0d6e2507-3669-441e-b5ba-86087fd2955d	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408
Natroba	SPINOSAD	ParaPRO LLC	fa90ccc8-2df0-49f7-8878-2b33e34cd272	2021-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408 ndc (product): 52246-929

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
28595-570	Spinosad	spinosad	Allegis Pharmaceuticals, LLC	NDA	Current
28595-570	Spinosad	spinosad	Allegis Pharmaceuticals, LLC	NDA	Current
28595-570	Spinosad	spinosad	Allegis Pharmaceuticals, LLC	NDA	Current
52246-929	Natroba	spinosad	ParaPRO LLC	NDA	Current
52246-929	Natroba	spinosad	ParaPRO LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67380	SUPPL	2021-05-03
67276	SUPPL	2021-04-30
7340	SUPPL	2015-01-07
38668	SUPPL	2015-01-05
24299	ORIG	2011-02-17
42511	ORIG	2011-02-16
29698	ORIG	2011-01-20
17552	ORIG	2011-01-19
68902	SUPPL	1900-01-01
67208	SUPPL	1900-01-01
67207	SUPPL	1900-01-01
63562	ORIG	1900-01-01
63561	ORIG	1900-01-01
63560	ORIG	1900-01-01
63559	ORIG	1900-01-01
51488	SUPPL	1900-01-01
51483	SUPPL	1900-01-01