Application 021903

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOPROFEN	IBUPROFEN LYSINE	INJECTABLE;INTRAVENOUS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021903-001	NEOPROFEN	IBUPROFEN LYSINE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021903-001	AP

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
N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11

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 · 41 observed states.

Captured, Edition, Application-product table
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	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021903-001	NEOPROFEN	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-04-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021903-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021903-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021903-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021903-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021903-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021903-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021903-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021903-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021903-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021903-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021903-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021903-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021903-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021903-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021903-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021903-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021903-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021903-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021903-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021903-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021903-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021903-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021903-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021903-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021903-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021903-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021903-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021903-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021903-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021903-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021903-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021903-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021903-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021903-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021903-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021903-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021903-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021903-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021903-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021903-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021903-001	6342530	2020-11-14	U-1127	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021903-001	6342530	2020-11-14	U-794	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021903-001	6344479	2021-03-20	U-794	Drug substance, Drug product, Delist requested		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021903-001	6342530	2020-11-14	U-1127	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021903-001	6342530	2020-11-14	U-794	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021903-001	6344479	2021-03-20	U-794	Drug substance, Drug product, Delist requested		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021903-001	6342530	2020-11-14	U-1127	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021903-001	6342530	2020-11-14	U-794	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021903-001	6344479	2021-03-20	U-794	Drug substance, Drug product, Delist requested		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021903-001	6342530	2020-11-14	U-1127	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021903-001	6342530	2020-11-14	U-794	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021903-001	6344479	2021-03-20	U-794	Drug substance, Drug product, Delist requested		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021903-001	8415337	2032-03-02		Drug substance, Drug product	2013-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021903-001	6342530	2020-11-14	U-1127	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021903-001	6342530	2020-11-14	U-794	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021903-001	6344479	2021-03-20	U-794	Drug substance, Drug product, Delist requested		`b00525d2431f…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Lysine	IBUPROFEN LYSINE	Prasco Laboratories	307431c7-12de-21e5-e054-00144ff88e88	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021903 application number: NDA021903 ndc (product): 66993-490
NEOPROFEN	IBUPROFEN LYSINE	Recordati Rare Diseases Inc.	6f5ede6f-b0b7-4fc8-969e-652f60ead047	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021903 application number: NDA021903 ndc (product): 55292-122

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-122	NeoProfen	ibuprofen lysine	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-122	NEOPROFEN	ibuprofen lysine	Recordati Rare Diseases Inc.	NDA	Current
55292-122	NEOPROFEN	ibuprofen lysine	Recordati Rare Diseases Inc.	NDA	Current
55292-122	NeoProfen	ibuprofen lysine	RECORDATI RARE DISEASES INC.	NDA	Current
55292-122	NeoProfen	ibuprofen lysine	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-122	NeoProfen	ibuprofen lysine	RECORDATI RARE DISEASES INC.	NDA	Current
66993-490	Ibuprofen Lysine	ibuprofen lysine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-490	Ibuprofen Lysine	ibuprofen lysine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-490	Ibuprofen Lysine	ibuprofen lysine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75972	SUPPL	2023-10-27
66914	SUPPL	2021-03-30
66900	SUPPL	2021-03-29
59706	SUPPL	2019-08-15
50092	SUPPL	2017-10-18
50068	SUPPL	2017-10-17
16544	SUPPL	2016-01-26
6420	SUPPL	2016-01-15
6419	SUPPL	2013-12-05
37847	SUPPL	2013-12-04
16543	SUPPL	2010-01-04
6418	SUPPL	2009-12-31
6417	SUPPL	2008-09-16
21864	ORIG	2008-04-22
37846	ORIG	2006-04-14