Application 070976

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	0.3MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070976-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	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
A070976-001	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	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	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	A070976-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070976-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070976-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070976-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070976-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070976-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070976-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070976-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070976-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070976-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070976-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070976-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070976-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070976-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070976-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070976-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070976-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070976-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070976-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070976-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070976-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070976-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070976-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070976-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070976-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070976-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070976-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070976-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070976-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070976-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070976-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070976-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070976-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070976-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070976-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070976-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070976-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070976-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070976-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070976-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976 ndc (product): 68001-239
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	acdddd91-ffe3-4b9b-9c59-0328e018b662	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976 ndc (product): 0615-2574
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976 ndc (product): 0228-2129
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e9b22c56-a3fc-46df-b745-11c4ac309a91	2017-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976 ndc (product): 43353-316

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2129	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2129	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0615-2574	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-2574	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-2574	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-2574	Clonidine Hydrochloride	Clonidine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-5658	Clonidine Hydrochloride	Clonidine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5658	Clonidine Hydrochloride	Clonidine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5658	Clonidine Hydrochloride	Clonidine Hydrochloride	Major Pharmaceuticals	ANDA	Current
10544-042	Clonidine Hydrochloride	Clonidine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
43353-316	Clonidine Hydrochloride	Clonidine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1652	Clonidine Hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
53808-0162	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	State of Florida DOH Central Pharmacy	NDA	Current
53808-0231	Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
68001-239	Clonidine Hydrochloride	Clonidine Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-239	Clonidine Hydrochloride	Clonidine Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-239	Clonidine Hydrochloride	Clonidine Hydrochloride	BluePoint Laboratories	ANDA	Current
68071-4721	Clonidine Hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4721	Clonidine Hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1811	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1811	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1811	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1811	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1811	Clonidine Hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current