Application 070975

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070975-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		1986-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070975-001	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 · 41 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	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A070975-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070975-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070975-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070975-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070975-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070975-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070975-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070975-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070975-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070975-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070975-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070975-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070975-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070975-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070975-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070975-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070975-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070975-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070975-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070975-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070975-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070975-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070975-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070975-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070975-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070975-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070975-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070975-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070975-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070975-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070975-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070975-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070975-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070975-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070975-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070975-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070975-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070975-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070975-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070975-001	AB	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	547beb0f-0c12-2ef4-e063-6394a90a6a73	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	266af0b1-ce85-6699-e063-6394a90acb4d	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 55154-2577
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	18c873b1-f2fe-4ba9-b384-38e917af373b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 51655-362
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 68001-238
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	4b889e12-0382-4679-9cec-d6829c59e853	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2e4802eb-c08b-45a2-a222-b0af5db88c7a	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 0615-8272
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	b4733c99-656d-4049-9422-3732492dd6ed	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 60687-124
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 0228-2128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2128	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2128	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0615-2573	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8272	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8272	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5657	Clonidine Hydrochloride	Clonidine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5657	Clonidine Hydrochloride	Clonidine Hydrochloride	Major Pharmaceuticals	ANDA	Current
50090-2950	Clonidine Hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3151	Clonidine Hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3151	Clonidine Hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3151	Clonidine Hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3151	Clonidine Hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
51655-362	Clonidine Hydrochloride	Clonidine Hydrochloride	Northwind Pharmaceuticals, LLC	ANDA	Current
53002-4941	Clonidine Hydrochloride	Clonidine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-2577	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-2577	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55154-7997	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55154-7997	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55154-7997	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55700-309	Clonidine Hydrochloride	Clonidine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-124	Clonidine Hydrochloride	Clonidine Hydrochloride	American Health Packaging	ANDA	Current
60687-124	Clonidine Hydrochloride	Clonidine Hydrochloride	American Health Packaging	ANDA	Current
67046-327	Clonidine Hydrochloride	Clonidine Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
68001-238	Clonidine Hydrochloride	Clonidine Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-238	Clonidine Hydrochloride	Clonidine Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-238	Clonidine Hydrochloride	Clonidine Hydrochloride	BluePoint Laboratories	ANDA	Current
68071-4601	Clonidine Hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4601	Clonidine Hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7685	Clonidine Hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7685	Clonidine Hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7685	Clonidine Hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9213	Clonidine Hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1774	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1959	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1959	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1959	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1959	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1959	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current