Application 076157

Type: ANDA
Sponsor: AVEVA

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 1.

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	Approval date
A076157-001	CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	2009-08-18
A076157-002	CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	2009-08-18
A076157-003	CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	2009-08-18

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 · 123 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	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL		2009-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL		2009-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL		2009-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL		2009-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL		2009-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL		2009-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076157-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076157-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076157-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2009-08-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A076157-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076157-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076157-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076157-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076157-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076157-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076157-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076157-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076157-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076157-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076157-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076157-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076157-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076157-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076157-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076157-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076157-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076157-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076157-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076157-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076157-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076157-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076157-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076157-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076157-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076157-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076157-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076157-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076157-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076157-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076157-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076157-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076157-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076157-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076157-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076157-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076157-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076157-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076157-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076157-001	AB	1	`5d02ea3f76ae…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexiclon XR	CLONIDINE	Rosemont Pharmaceuticals LLC	dad35a6f-d57e-f302-e053-2995a90a9efb	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE
Clonidine	CLONIDINE	Ingenus Pharmaceuticals, LLC	99485427-a120-4fc7-bb61-25857d1900ec	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE
Clonidine	CLONIDINE	Mayne Pharma Inc.	c41eb913-5e47-46c4-9d96-9a67f8380919	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE
Clonidine	CLONIDINE	Dr. Reddy's Labratories Inc.	a179570b-eef1-176a-820c-5f603d222a60	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE
Clonidine	CLONIDINE	XGen Pharmaceuticals DJB, Inc.	ada02f1f-ae78-4435-879e-492ae862d504	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE
Clonidine	CLONIDINE	TruPharma, LLC	2311836b-de63-4e8c-a021-600c40110024	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE
Clonidine	CLONIDINE	PALMETTO PHARMACEUTICALS INC.	e93324f1-ad83-7bbe-e053-2995a90a8c9e	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE
Clonidine transdermal system	CLONIDINE	Actavis Pharma, Inc.	99a59495-2a48-4276-bbe3-cdd55a45aba4	2023-11-28	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE
Clonidine	CLONIDINE	Mylan Pharmaceuticals Inc.	7adfc439-e6d0-4593-87dd-0eef36d33c6d	2023-03-29	Warnings, Adverse reactions	Name fallback brand name: Clonidine generic name: CLONIDINE