Application 070923

Type: ANDA
Sponsor: FRONTIDA BIOPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	No	No
004	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.05MG	No	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
A070923-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB		1987-09-04
A070923-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		1987-09-04
A070923-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		1987-09-04
A070923-004	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.05MG	TABLET / ORAL		RS	2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A070923-001	AB
A070923-002	AB
A070923-003	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 4 · 124 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	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A070923-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070923-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070923-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070923-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	f65d90dc-11b4-4d63-b4a9-30603bc332ea	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923 ndc (product): 71335-1624
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544ea5bf-6713-f034-e063-6394a90a781b	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	TruPharma, LLC	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923 ndc (product): 52817-182
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	f30324be-47b6-7f54-e053-2995a90a3ad4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	e8c7aa08-1450-de68-e053-2995a90ad0b6	2022-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923 ndc (product): 76420-286
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	00d1562d-b4eb-4d89-95de-0aacee7a82a5	2020-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923 ndc (product): 71610-449

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-377	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	Rebel Distributors Corp	ANDA	Current
50090-2178	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	A-S Medication Solutions	ANDA	Current
50436-3526	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	Unit Dose Services	ANDA	Current
50436-3526	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	Unit Dose Services	ANDA	Current
51138-019	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	Med-Health Pharma, LLC	ANDA	Current
52817-182	Clonidine hydrochloride	Clonidine hydrochloride	TruPharma, LLC	ANDA	Current
52817-182	Clonidine hydrochloride	Clonidine hydrochloride	TruPharma, LLC	ANDA	Current
52817-182	Clonidine hydrochloride	Clonidine hydrochloride	TruPharma, LLC	ANDA	Current
53489-217	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	Mutual Pharmaceutical Company, Inc.	ANDA	Current
54738-909	Clonidine Hydrochloride	Clonidine Hydrochloride	Richmond Pharmaceuticals, Inc.	ANDA	Current
70934-752	Clonidine hydrochloride	Clonidine hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-1624	Clonidine hydrochloride	Clonidine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1624	Clonidine hydrochloride	Clonidine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-449	Clonidine hydrochloride	Clonidine hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76420-286	Clonidine hydrochloride	Clonidine hydrochloride	Asclemed USA, Inc.	ANDA	Current