Application 090873

Type: ANDA
Sponsor: ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE	CLONIDINE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	No	No
002	CLONIDINE	CLONIDINE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/24HR	No	No
003	CLONIDINE	CLONIDINE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.3MG/24HR	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090873-001	CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06
A090873-002	CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06
A090873-003	CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090873-001	AB
A090873-002	AB
A090873-003	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 4 · 126 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	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090873-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090873-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090873-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2014-05-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090873-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090873-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090873-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090873-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090873-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090873-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090873-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090873-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090873-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090873-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090873-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090873-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090873-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090873-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090873-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090873-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090873-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090873-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090873-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090873-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090873-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090873-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090873-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090873-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090873-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090873-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090873-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090873-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090873-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090873-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090873-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090873-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090873-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090873-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090873-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090873-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090873-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090873-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090873-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090873-001	AB	1	`1e350fbaab3a…`

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 transdermal system	CLONIDINE	Actavis Pharma, Inc.	99a59495-2a48-4276-bbe3-cdd55a45aba4	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090873 application number: ANDA090873 ndc (product): 0591-3508 ndc (product): 0591-3510 ndc (product): 0591-3509

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3508	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3508	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3508	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3508	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3508	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3509	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3509	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3509	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3509	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3509	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3510	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3510	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3510	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3510	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current
0591-3510	Clonidine transdermal system	Clonidine	Actavis Pharma, Inc.	ANDA	Current