Application 077901

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077901-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09
A077901-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09
A077901-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077901-001	AB
A077901-002	AB
A077901-003	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 · 123 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	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077901-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2007-03-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077901-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2007-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077901-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2007-03-09	`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	A077901-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077901-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077901-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077901-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077901-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077901-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077901-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077901-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077901-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077901-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077901-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077901-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077901-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077901-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077901-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077901-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077901-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077901-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077901-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077901-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077901-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077901-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077901-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077901-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077901-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077901-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077901-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077901-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077901-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077901-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077901-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077901-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077901-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077901-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077901-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077901-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077901-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077901-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077901-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077901-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	32e740a9-51e1-4add-8f99-523fb9cb8b2e	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077901 application number: ANDA077901
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Major Pharmaceuticals	8171776a-dd14-4dcc-8860-3c27d8ea9504	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077901 application number: ANDA077901
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Solco Healthcare LLC	2bbfea75-9241-4c3a-84f5-342ccb3cdf16	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077901 application number: ANDA077901 ndc (product): 43547-567 ndc (product): 43547-565 ndc (product): 43547-566

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-196	Clonidine Hydrochloride	clonidine hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-199	Clonidine Hydrochloride	clonidine hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
33261-623	Clonidine Hydrochloride	clonidine hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
43547-565	Clonidine Hydrochloride	clonidine hydrochloride	Solco Healthcare LLC	ANDA	Current
43547-566	Clonidine Hydrochloride	clonidine hydrochloride	Solco Healthcare LLC	ANDA	Current
43547-567	Clonidine Hydrochloride	clonidine hydrochloride	Solco Healthcare LLC	ANDA	Current
53808-0828	Clonidine Hydrochloride	clonidine hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0926	Clonidine Hydrochloride	clonidine hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0943	Clonidine Hydrochloride	clonidine hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0947	Clonidine Hydrochloride	clonidine hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55045-1167	Clonidine Hydrochloride	Clonidine Hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
64725-2957	Clonidine Hydrochloride	clonidine hydrochloride	TYA Pharmaceuticals	ANDA	Current
66336-786	Clonidine Hydrochloride	clonidine hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
68788-9535	Clonidine Hydrochloride	clonidine hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current