Application 202984

Type: ANDA
Sponsor: ANCHEN PHARMS

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
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202984-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL			2013-09-30
A202984-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL			2013-09-30

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2013-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2013-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2013-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2013-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202984-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2013-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202984-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202984-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202984-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202984-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202984-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202984-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202984-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202984-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202984-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202984-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202984-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202984-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202984-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202984-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202984-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202984-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202984-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202984-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202984-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202984-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202984-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202984-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202984-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202984-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202984-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202984-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202984-001	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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	58772b44-dec0-7001-e063-6394a90ac40e	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e5d24f52-e0c2-428d-b647-481d63ffd95f	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Major Pharmaceuticals	8171776a-dd14-4dcc-8860-3c27d8ea9504	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e96ab74c-eedf-4d71-8a35-d5ec3daa7592	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	574640a5-829d-4e9d-be32-832a48cbd8dd	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	2a183d05-5be7-43e9-a084-700ec05d01e9	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	32d72d7b-5881-f431-e063-6394a90a3547	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	cee049ea-a476-433c-971f-2466a6a3263b	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	f65d90dc-11b4-4d63-b4a9-30603bc332ea	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	547beb0f-0c12-2ef4-e063-6394a90a6a73	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544ea5bf-6713-f034-e063-6394a90a781b	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	7ec53e25-c50a-48b4-82b0-c0b3626f31dc	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ea1527a5-4939-4ff7-a827-f88a9113a07d	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	be1b921d-152e-4bd5-82bd-56e2f8beef3e	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	ASCLEMED USA INC.	200afa03-adf3-4dca-8de8-1569701bd029	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	266af0b1-ce85-6699-e063-6394a90acb4d	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	666e757e-9b43-2e40-e053-2991aa0a59a2	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	50c8a725-a449-256b-e063-6294a90a3e44	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10370-257	Clonidine Hydrochloride	Clonidine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
10370-257	Clonidine Hydrochloride	Clonidine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
10370-302	Clonidine Hydrochloride	Clonidine Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
42291-148	Clonidine Hydrochloride	Clonidine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-148	Clonidine Hydrochloride	Clonidine Hydrochloride	AvKARE	ANDA	Current
60429-431	Clonidine Hydrochloride	Clonidine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-431	Clonidine Hydrochloride	Clonidine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-431	Clonidine Hydrochloride	Clonidine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
68084-866	Clonidine Hydrochloride	Clonidine Hydrochloride	American Health Packaging	ANDA	Current
68084-866	Clonidine Hydrochloride	Clonidine Hydrochloride	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32345	ORIG	2013-10-01