Application 209686

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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 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
A209686-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209686-001	AB1

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`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	A209686-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209686-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209686-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209686-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209686-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209686-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209686-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209686-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209686-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209686-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209686-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209686-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209686-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209686-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209686-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209686-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209686-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209686-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209686-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209686-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209686-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209686-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209686-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209686-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209686-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209686-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209686-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209686-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209686-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209686-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209686-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209686-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209686-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209686-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209686-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209686-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209686-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209686-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209686-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209686-001	AB1	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	df80255e-f942-4d9f-8edd-cc95795772cb	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209686 application number: ANDA209686 ndc (product): 27241-108
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	f34ae077-4ace-4e0a-bc87-d559b1c5bf2f	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209686 application number: ANDA209686
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	95b390cc-0578-4cb0-9c08-4853388b2ec9	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209686 application number: ANDA209686 ndc (product): 60687-462

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-108	Clonidine hydrochloride	Clonidine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-108	Clonidine hydrochloride	Clonidine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-108	Clonidine hydrochloride	Clonidine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-108	Clonidine hydrochloride	Clonidine hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-108	Clonidine hydrochloride	Clonidine hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
55700-802	Clonidine hydrochloride	Clonidine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-802	Clonidine hydrochloride	Clonidine hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-802	Clonidine hydrochloride	Clonidine hydrochloride	Quality Care Products, LLC	ANDA	Current
60687-462	Clonidine hydrochloride	Clonidine hydrochloride	American Health Packaging	ANDA	Current
60687-462	Clonidine hydrochloride	Clonidine hydrochloride	American Health Packaging	ANDA	Current
60687-462	Clonidine hydrochloride	Clonidine hydrochloride	American Health Packaging	ANDA	Current
70518-3350	Clonidine hydrochloride	Clonidine hydrochloride	REMEDYREPACK INC.	ANDA	Current