Application 071785

Type: ANDA
Sponsor: CHARTWELL MOLECULES

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	0.1MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071785-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05
A071785-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05
A071785-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071785-001	AB
A071785-002	AB
A071785-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071785-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071785-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071785-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-04-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071785-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071785-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071785-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071785-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071785-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071785-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071785-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071785-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071785-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071785-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071785-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071785-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071785-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071785-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071785-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071785-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071785-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071785-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071785-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071785-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071785-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071785-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071785-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071785-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071785-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071785-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071785-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071785-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071785-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071785-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071785-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071785-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071785-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071785-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071785-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071785-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071785-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071785-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071785-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071785-001	AB	1	`301d65b070ca…`

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 5 of 6 · 113 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	1df79865-c028-45c7-8580-9908eec80979	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	be6c29cd-1692-4dd3-868e-7efcb3a85056	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	849cafb5-0a98-4434-80bb-b16e7109dd06	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	415b168c-1267-2777-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	acdddd91-ffe3-4b9b-9c59-0328e018b662	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2e4802eb-c08b-45a2-a222-b0af5db88c7a	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a9de8b29-5cd2-a49d-e053-2995a90a4f0e	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	36bd0f0e-5569-466a-ab1b-90eb39efdd68	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	95b390cc-0578-4cb0-9c08-4853388b2ec9	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0bde4636-7f34-467e-b9b9-8d281145177d	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Solco Healthcare LLC	03a53175-d301-4001-b28b-78ecd763c4ae	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	88c11229-7eed-4fed-983f-503b78f03383	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	b4733c99-656d-4049-9422-3732492dd6ed	2024-04-23	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	DirectRX	2823a922-3217-6062-e054-00144ff88e88	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: CLONIDINE HYDROCHLORIDE generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	22fbd302-46b5-4bdc-87e2-fda94cb22530	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	745c8731-63e0-47ce-96d3-6a4d21c655e2	2023-12-12	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	893a6cf5-d34e-4971-b132-3f5138e481ce	2023-11-30	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	0100c70d-7fde-46a1-8374-940550a27e43	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	8427eee0-955d-4718-b259-73dab56d36d2	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Solco Healthcare LLC	2bbfea75-9241-4c3a-84f5-342ccb3cdf16	2023-05-25	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.