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 3 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	Northwind Health Company, LLC	df603f27-d341-3957-e053-2995a90a825f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	f30324be-47b6-7f54-e053-2995a90a3ad4	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	df77e732-9765-ee5c-e053-2a95a90abc92	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	18c873b1-f2fe-4ba9-b384-38e917af373b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	VERITYRX, LLC	42788adf-a54d-3545-e063-6394a90a8c69	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	VERITYRX, LLC	427939a4-6bbf-0d80-e063-6294a90aa2a0	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	df80255e-f942-4d9f-8edd-cc95795772cb	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	60171b1d-03af-4849-a030-6260192b11ce	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	d072d601-b3d2-46e0-af1f-98adc9572f4a	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: CLONIDINE HYDROCHLORIDE generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	5bc6188d-5b51-4dee-a12d-f2d5e42eb88d	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	300b4437-74b3-119b-e063-6394a90a0d0f	2025-08-30	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	f34ae077-4ace-4e0a-bc87-d559b1c5bf2f	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	746dcdfd-7dfb-4a29-e053-2991aa0a8a4c	2025-05-07	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
ONYDA XR	CLONIDINE HYDROCHLORIDE	NextWave Pharmaceuticals, Inc	4a15c850-9da5-4bdc-a34d-7f740a6149b7	2025-04-11	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	325f382b-6c04-2608-e063-6394a90a3872	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	122f6904-bb63-42c5-b000-f4f5c75586cc	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	d2f80661-34c4-42ff-b1c2-3ab8f9d9ef4d	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	075b6261-9064-41da-b5e0-0959767e0d9a	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	100a31f2-9a8e-4245-a09c-05583c3244c3	2025-03-31	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.