Application 205430

Type: ANDA
Sponsor: APOTEX

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A205430-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25
A205430-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25
A205430-003	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25
A205430-004	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205430-001	AB
A205430-002	AB
A205430-003	AB
A205430-004	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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205430-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205430-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205430-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205430-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205430-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205430-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205430-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205430-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205430-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205430-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-004	AB	1	`5bbf6a4d5a75…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guanfacine extended-release	GUANFACINE	REMEDYREPACK INC.	8348e63a-5cbc-489e-b7bf-046c65ba2e8e	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Apotex Corp.	1c492e87-3406-ddb8-aaf2-e609c2ded503	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430 ndc (product): 60505-3929 ndc (product): 60505-3930 ndc (product): 60505-3928 ndc (product): 60505-3927
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	1c5d9514-641a-4c72-a79a-96a0fe5d6fbd	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	07cda4a1-0eb5-491e-8d16-4e6a6feb93ac	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	187bd24b-d69b-4cdf-be4a-c89e9b131b81	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	178b649f-8c0f-4fea-a168-3ce4ff52129d	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine ER	GUANFACINE ER	Direct_Rx	fae2df3c-2298-a3e1-e053-6294a90aeac4	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	A-S Medication Solutions	07797c4a-a799-436b-a77c-a2861a811a99	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430

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 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3927	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3928	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3929	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current
60505-3930	Guanfacine extended-release	guanfacine	Apotex Corp.	ANDA	Current