Application 203320

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, 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 1.

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
A203320-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2015-05-15
A203320-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL			2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203320-001	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 3 · 82 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	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`782e0a99824c…`

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	A203320-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203320-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203320-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203320-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203320-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203320-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203320-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203320-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203320-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203320-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203320-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203320-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203320-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203320-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203320-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203320-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203320-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203320-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203320-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203320-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203320-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203320-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203320-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203320-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203320-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203320-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203320-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203320-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203320-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203320-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203320-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203320-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203320-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203320-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203320-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203320-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203320-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203320-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203320-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203320-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	0100c70d-7fde-46a1-8374-940550a27e43	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203320 application number: ANDA203320 ndc (product): 0228-4241

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-4241	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-4241	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-4241	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-4241	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-4241	Clonidine Hydrochloride	Clonidine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
63629-7765	Clonidine Hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7765	Clonidine Hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current