Application 090329

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090329-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03
A090329-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03
A090329-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090329-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	2014-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090329-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	2014-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090329-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	2014-07-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A090329-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090329-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090329-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090329-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090329-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090329-003	AB	1	`ea99ee380514…`

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 2 of 6 · 113 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	TruPharma, LLC	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	32e740a9-51e1-4add-8f99-523fb9cb8b2e	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	b359baee-6faf-4f7d-be86-ba7a1b1de770	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	0906c25f-e5b8-4a08-9b10-d1f06419e275	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	c8e151d6-50c6-47a1-80b0-bd8e07acddd2	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e413efdf-980b-4b33-80f1-5be899a10f01	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	55ab721b-7b4c-42d5-99e3-745008fe139c	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	56a80e79-9cfe-4361-a90a-9245632efa05	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	770b56aa-fcf3-4327-98d1-d87e5a037234	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	21bfa28f-20df-43fd-bb80-b720d3b40696	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7484e8fa-13a7-70e9-e053-2a91aa0a24b7	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	a32f4b18-1090-4d79-a56b-39c0cf366bbc	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1ab3b82f-db7f-22bf-e063-6294a90ae93f	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	ab2ffb6e-7070-063b-e053-2a95a90aff22	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	66dc3cf0-d6bd-436c-9a7f-7477575b3260	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.