Application 202568

Type: ANDA
Sponsor: SANDOZ INC

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 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	Approval date
A202568-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03
A202568-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03
A202568-003	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03
A202568-004	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202568-001	AB
A202568-002	AB
A202568-003	AB
A202568-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202568-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202568-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202568-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202568-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-03	`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	A202568-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202568-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202568-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202568-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202568-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202568-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202568-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202568-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202568-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202568-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202568-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202568-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202568-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202568-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202568-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202568-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202568-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202568-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202568-004	AB	1	`d06236e962d9…`

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 · 13 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	Name fallback brand name: Guanfacine Hydrochloride
Guanfacine Hydrochloride	GUANFACINE	Amneal Pharmaceuticals of New York LLC	73d50917-c807-4213-8efe-aea209845936	2026-04-14	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	REMEDYREPACK INC.	1b1063ba-fee3-4540-9139-db4b915f82e2	2026-04-10	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE	AvPAK	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	2026-02-24	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride
GUANFACINE HYDROCHLORIDE	GUANFACINE	Chartwell RX, LLC	fa7ae501-ee34-4e50-9052-7952e36bbd0e	2025-12-10	Adverse reactions	Name fallback brand name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE	Precision Dose, Inc.	a80dfdc4-b9a7-4f8e-af67-dea30bc063ac	2025-05-27	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride
Guanfacine Hydrochloride	GUANFACINE	Amneal Pharmaceuticals LLC	d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e	2024-10-25	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	American Health Packaging	c38bf26f-8a98-4baa-9abb-c83f812900a1	2024-08-29	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	NORTHSTAR RX LLC	83d0739b-46fd-6228-e85c-089611067a35	2024-07-15	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	XIROMED, LLC	4f1e668a-37dd-44f4-ae99-3a1f6dba3eea	2024-02-24	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE	TWi Pharmaceuticals, Inc.	a0c2d95d-805c-4c7d-9733-52073a65218a	2023-09-04	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride
GUANFACINE	GUANFACINE HYDROCHLORIDE	Aurobindo Pharma Limited	e6d4fc3d-4169-44f1-bcb9-1188de40d4e5	2023-08-08	Adverse reactions	Name fallback generic name: GUANFACINE HYDROCHLORIDE
Guanfacine Hydrochloride	GUANFACINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	14146031-8d56-469b-8de8-fe3cf1712e78	2021-03-30	Adverse reactions	Name fallback brand name: Guanfacine Hydrochloride generic name: GUANFACINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5451	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5451	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5452	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5452	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5456	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5456	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5457	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current
0781-5457	Guanfacine	Guanfacine	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10072	ORIG	2015-06-10