Application 210680

Type: ANDA
Sponsor: MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.1MG	No	No

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

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
A210680-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL			2018-04-30

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 · 43 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	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210680-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-04-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210680-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210680-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210680-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210680-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210680-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210680-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210680-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210680-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210680-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210680-001	AB1	1	`ea99ee380514…`

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 4 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	1c13555e-acfc-4a3a-93cd-e6f012f36c61	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	029ed62c-67cb-406f-84e4-702aebfa7d68	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	74b40ae9-a9d7-443e-8d7a-80362ec5be6d	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	6c95c495-f630-45c1-92c3-8c0fdb22013c	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4b087e-a81a-1321-e053-2995a90a2b9f	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Somerset Therapeutics, LLC	1b4fb182-8194-4fdd-bf9b-f7e60e734179	2025-03-07	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5366a055-47fd-41eb-81d8-ffb3be1dc38c	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	61b56917-1442-4068-86d8-0e5a5a59e612	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cd64137-09d7-7a00-e053-2a91aa0a06ae	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	AvPAK	fcebe343-18ad-d4cd-e053-6294a90a72d5	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	329382fb-ccf8-488d-a0b2-68ff959a0846	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	aecd05bf-e7ba-4cab-9494-4ce3bbd1aa99	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	d3b099db-698e-4ea8-a6df-42dc79234597	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	c5c85b76-4d5c-47f0-bafb-31efe1fbaed3	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	9d889b1c-9599-44fa-9e47-6261fbf2837e	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	c7f473df-94ab-41db-8cc7-9a159d5e6dc4	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	0f8adf88-26a4-4dd1-bfbb-784a528641e6	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	1c65bafb-9752-4785-84b1-376cf863fd07	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	70c0c9f4-075d-4621-ae13-e8f03d814d5f	2024-09-05	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-839	clonidine hydrochloride	clonidine hydrochloride	Northstar Rx LLC	ANDA	Current
16714-839	clonidine hydrochloride	clonidine hydrochloride	Northstar Rx LLC	ANDA	Current
16714-839	clonidine hydrochloride	clonidine hydrochloride	Northstar Rx LLC	ANDA	Current
51862-060	clonidine hydrochloride	clonidine hydrochloride	Mayne Pharma Inc.	ANDA	Current
51862-060	clonidine hydrochloride	clonidine hydrochloride	Mayne Pharma Inc.	ANDA	Current