Application 022522

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DALIRESP	ROFLUMILAST	TABLET;ORAL	500MCG	Yes	Yes
002	DALIRESP	ROFLUMILAST	TABLET;ORAL	250MCG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022522-001	DALIRESP	ROFLUMILAST	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28
N022522-002	DALIRESP	ROFLUMILAST	250MCG	TABLET / ORAL	AB	RLD	2018-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022522-001	AB
N022522-002	AB

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 3 · 82 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	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	N022522-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022522-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022522-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022522-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022522-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022522-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022522-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022522-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022522-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022522-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022522-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022522-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022522-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022522-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022522-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022522-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022522-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022522-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022522-001	AB	1	`b00525d2431f…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 318 observed states.

Captured, Edition, Application-product table
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	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022522-001	M-208	2020-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022522-001	D-171	2021-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022522-002	NS	2021-01-23	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022522-001	D-171	2021-01-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022522-002	NS	2021-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022522-001	D-171	2021-01-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022522-002	NS	2021-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022522-001	D-171	2021-01-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022522-002	NS	2021-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022522-001	M-208	2020-08-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022522-001	D-171	2021-01-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022522-002	NS	2021-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022522-001	M-208	2020-08-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022522-001	D-171	2021-01-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022522-002	NS	2021-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022522-001	M-208	2020-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022522-001	D-171	2021-01-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022522-002	NS	2021-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022522-001	M-208	2020-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022522-001	D-171	2021-01-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022522-002	NS	2021-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022522-001	M-208	2020-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022522-001	D-171	2021-01-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022522-002	NS	2021-01-23	`ea99ee380514…`

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
Daliresp	ROFLUMILAST	AstraZeneca Pharmaceuticals LP	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	2020-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022522 application number: NDA022522 ndc (product): 0310-0095 ndc (product): 0310-0088

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
0310-0088	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0088	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0088	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0088	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0095	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0095	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0095	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0095	Daliresp	roflumilast	AstraZeneca Pharmaceuticals LP	NDA	Current
55154-4625	Daliresp	roflumilast	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
51720	SUPPL	2018-01-25
51710	SUPPL	2018-01-25
51709	SUPPL	2018-01-25
49657	SUPPL	2017-09-01
49647	SUPPL	2017-09-01
29824	SUPPL	2015-11-25
17675	SUPPL	2015-11-25
38808	SUPPL	2013-08-27
29823	SUPPL	2013-08-27
44769	ORIG	2011-04-14
42548	ORIG	2011-04-14
38807	ORIG	2011-03-10
7496	ORIG	2011-03-07