Application 022037

Type: NDA
Sponsor: SHIRE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTUNIV	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	Yes	No
002	INTUNIV	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	Yes	No
003	INTUNIV	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE	Yes	No
004	INTUNIV	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	Yes	Yes

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

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	TE codes	RLD / RS	Approval date
N022037-001	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02
N022037-002	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02
N022037-003	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02
N022037-004	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022037-001	AB
N022037-002	AB
N022037-003	AB
N022037-004	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 5 · 164 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	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N022037-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022037-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022037-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-001	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-002	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-003	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-004	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022037-001	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-002	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-003	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-004	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022037-001	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-002	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-003	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-004	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`

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
Intuniv	GUANFACINE	Takeda Pharmaceuticals America, Inc.	b972af81-3a37-40be-9fe1-3ddf59852528	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022037 application number: NDA022037 ndc (product): 54092-519 ndc (product): 54092-513 ndc (product): 54092-515 ndc (product): 54092-520 ndc (product): 54092-517

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-513	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-513	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-513	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-513	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-513	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-515	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-515	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-515	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-515	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-515	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-517	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-517	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-517	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-517	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-517	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-519	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-519	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-519	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-519	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-519	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-520	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-520	Intuniv	guanfacine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-520	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
54092-520	Intuniv	guanfacine	Shire US Manufacturing Inc.	NDA	Current
64725-0513	Intuniv	guanfacine	TYA Pharmaceuticals	NDA	Current
64725-0515	Intuniv	guanfacine	TYA Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61565	SUPPL	2020-01-14
61498	SUPPL	2020-01-14
58512	SUPPL	2019-05-02
58499	SUPPL	2019-05-01
53000	SUPPL	2018-03-15
52878	SUPPL	2018-03-08
50555	SUPPL	2017-12-01
50513	SUPPL	2017-11-28
6741	SUPPL	2016-07-12
16811	SUPPL	2016-07-08
16810	SUPPL	2015-03-19
6740	SUPPL	2015-03-19
38121	SUPPL	2014-11-20
29123	SUPPL	2014-11-20
51938	SUPPL	2014-10-17
38120	SUPPL	2013-08-27
29122	SUPPL	2013-08-27
6739	SUPPL	2013-02-25
16809	SUPPL	2013-02-21
38119	SUPPL	2011-06-10
29121	SUPPL	2011-06-10
38118	SUPPL	2011-03-04
29120	SUPPL	2011-03-02
42396	ORIG	2010-07-09
24235	ORIG	2010-07-09
38117	ORIG	2009-10-01
6738	ORIG	2009-09-10
68898	ORIG	1900-01-01
68897	ORIG	1900-01-01
68896	ORIG	1900-01-01
67203	ORIG	1900-01-01
67202	ORIG	1900-01-01
67201	ORIG	1900-01-01
67149	ORIG	1900-01-01
67147	ORIG	1900-01-01
67145	ORIG	1900-01-01
54116	ORIG	1900-01-01
54115	ORIG	1900-01-01
54114	ORIG	1900-01-01
54113	ORIG	1900-01-01
54112	ORIG	1900-01-01
51167	SUPPL	1900-01-01
51166	SUPPL	1900-01-01
51165	SUPPL	1900-01-01
51164	SUPPL	1900-01-01
51159	SUPPL	1900-01-01
51158	SUPPL	1900-01-01
51156	SUPPL	1900-01-01