Application 075109

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	No	No
002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE	No	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
A075109-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25
A075109-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075109-001	AB
A075109-002	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	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1998-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075109-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075109-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075109-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075109-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075109-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075109-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075109-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075109-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075109-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075109-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075109-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075109-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075109-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075109-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075109-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075109-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075109-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075109-002	AB	1	`782e0a99824c…`

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
Guanfacine Hydrochloride	GUANFACINE	A-S Medication Solutions	9f967d68-5aff-4955-8c79-69febf7c38ad	2026-05-22	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109 ndc (product): 50090-6073
Guanfacine Hydrochloride	GUANFACINE	Amneal Pharmaceuticals of New York LLC	73d50917-c807-4213-8efe-aea209845936	2026-04-14	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109 ndc (product): 53746-711 ndc (product): 53746-713
Guanfacine Hydrochloride	GUANFACINE	AvPAK	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	2026-02-24	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109 ndc (product): 50268-374 ndc (product): 50268-373
Guanfacine Hydrochloride	GUANFACINE	Precision Dose, Inc.	a80dfdc4-b9a7-4f8e-af67-dea30bc063ac	2025-05-27	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109
Guanfacine Hydrochloride	GUANFACINE	Amneal Pharmaceuticals LLC	d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e	2024-10-25	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109 ndc (product): 65162-711 ndc (product): 65162-713

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0711	Guanfacine Hydrochloride	Guanfacine	Atlantic Biologicals Corps	ANDA	Current
42291-310	Guanfacine Hydrochloride	Guanfacine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-310	Guanfacine Hydrochloride	Guanfacine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-310	Guanfacine Hydrochloride	Guanfacine Hydrochloride	AvKARE	ANDA	Current
42291-310	Guanfacine Hydrochloride	Guanfacine Hydrochloride	AvKARE	ANDA	Current
42291-311	Guanfacine Hydrochloride	Guanfacine Hydrochloride	AvKARE, Inc.	ANDA	Current
50090-4119	Guanfacine Hydrochloride	Guanfacine	A-S Medication Solutions	ANDA	Current
50090-4119	Guanfacine Hydrochloride	Guanfacine	A-S Medication Solutions	ANDA	Current
50090-6073	Guanfacine Hydrochloride	Guanfacine	A-S Medication Solutions	ANDA	Current
50268-373	Guanfacine Hydrochloride	Guanfacine	AvPAK	ANDA	Current
50268-374	Guanfacine Hydrochloride	Guanfacine	AvPAK	ANDA	Current
50268-374	Guanfacine Hydrochloride	Guanfacine	AvPAK	ANDA	Current
50268-374	Guanfacine Hydrochloride	Guanfacine	AvPAK	ANDA	Current
50268-374	Guanfacine Hydrochloride	Guanfacine	AvPAK	ANDA	Current
53746-711	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-713	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
64725-0711	Guanfacine Hydrochloride	Guanfacine Hydrochloride	TYA Pharmaceuticals	ANDA	Current
65162-711	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-711	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-711	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-711	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-713	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-713	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-713	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-713	Guanfacine Hydrochloride	Guanfacine	Amneal Pharmaceuticals LLC	ANDA	Current
68084-748	Guanfacine Hydrochloride	Guanfacine Hydrochloride	American Health Packaging	ANDA	Current
68084-748	Guanfacine Hydrochloride	Guanfacine Hydrochloride	American Health Packaging	ANDA	Current
68084-748	Guanfacine Hydrochloride	Guanfacine Hydrochloride	American Health Packaging	ANDA	Current
68084-748	Guanfacine Hydrochloride	Guanfacine Hydrochloride	American Health Packaging	ANDA	Current
68094-019	Guanfacine	guanfacine	Precision Dose, Inc.	ANDA	Current
70518-0793	Guanfacine Hydrochloride	Guanfacine	REMEDYREPACK INC.	ANDA	Current
70518-0793	Guanfacine Hydrochloride	Guanfacine	REMEDYREPACK INC.	ANDA	Current
70518-0793	Guanfacine Hydrochloride	Guanfacine	REMEDYREPACK INC.	ANDA	Current
70518-0793	Guanfacine Hydrochloride	Guanfacine	REMEDYREPACK INC.	ANDA	Current