Application 214689

Type: ANDA
Sponsor: UNICHEM

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
A214689-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2021-03-03
A214689-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2021-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214689-001	AB
A214689-002	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 2 · 68 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
2026-02-19 14:30 UTC	2026-02	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214689-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2021-03-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214689-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2021-03-03	`87673890dc5c…`

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	A214689-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214689-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214689-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214689-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214689-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214689-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214689-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214689-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214689-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214689-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214689-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214689-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214689-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214689-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214689-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214689-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214689-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214689-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214689-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214689-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214689-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214689-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214689-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214689-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214689-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214689-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214689-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214689-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214689-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214689-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214689-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214689-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214689-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214689-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214689-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214689-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214689-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214689-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214689-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214689-002	AB	1	`87673890dc5c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	REMEDYREPACK INC.	1b1063ba-fee3-4540-9139-db4b915f82e2	2026-04-10	Adverse reactions	Exact identifier application applno (ANDA): 214689 application number: ANDA214689 ndc (product): 70518-3516
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	American Health Packaging	c38bf26f-8a98-4baa-9abb-c83f812900a1	2024-08-29	Adverse reactions	Exact identifier application applno (ANDA): 214689 application number: ANDA214689 ndc (product): 60687-710
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	14146031-8d56-469b-8de8-fe3cf1712e78	2021-03-30	Adverse reactions	Exact identifier application applno (ANDA): 214689 application number: ANDA214689 ndc (product): 29300-458 ndc (product): 29300-459

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-458	Guanfacine Hydrochloride	Guanfacine Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-458	Guanfacine Hydrochloride	Guanfacine Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-459	Guanfacine Hydrochloride	Guanfacine Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-459	Guanfacine Hydrochloride	Guanfacine Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
60687-710	Guanfacine Hydrochloride	Guanfacine Hydrochloride	American Health Packaging	ANDA	Current
68071-2719	Guanfacine Hydrochloride	Guanfacine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3516	Guanfacine Hydrochloride	Guanfacine Hydrochloride	REMEDYREPACK INC.	ANDA	Current