Application 202601

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/10ML (0.5MG/ML)	No	No

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

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
A202601-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2014-02-20
A202601-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP		2014-02-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202601-001	AP
A202601-002	AP

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 · 86 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
2026-09-14 22:38:34	2026-08	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202601-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202601-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	2014-02-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A202601-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202601-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202601-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202601-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202601-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202601-002	AP	1	`a50c72e98297…`

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 6 · 109 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	6d7cfb02-e580-4658-a2fe-2149b515d434	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	00c6d67a-bb11-4884-9eeb-4e1b8701a08b	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	4b889e12-0382-4679-9cec-d6829c59e853	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
QLONILIK	CLONIDINE HYDROCHLORIDE	CMP Pharma, Inc.	826de1dc-378e-4c90-86d1-e33f7a4248cd	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	58772b44-dec0-7001-e063-6394a90ac40e	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e5d24f52-e0c2-428d-b647-481d63ffd95f	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Major Pharmaceuticals	8171776a-dd14-4dcc-8860-3c27d8ea9504	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	574640a5-829d-4e9d-be32-832a48cbd8dd	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	2a183d05-5be7-43e9-a084-700ec05d01e9	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	32d72d7b-5881-f431-e063-6394a90a3547	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	cee049ea-a476-433c-971f-2466a6a3263b	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	f65d90dc-11b4-4d63-b4a9-30603bc332ea	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	547beb0f-0c12-2ef4-e063-6394a90a6a73	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544ea5bf-6713-f034-e063-6394a90a781b	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	7ec53e25-c50a-48b4-82b0-c0b3626f31dc	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ea1527a5-4939-4ff7-a827-f88a9113a07d	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	be1b921d-152e-4bd5-82bd-56e2f8beef3e	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	ASCLEMED USA INC.	200afa03-adf3-4dca-8de8-1569701bd029	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-601	clonidine hydrochloride	clonidine hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-601	clonidine hydrochloride	clonidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-601	clonidine hydrochloride	clonidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-602	clonidine hydrochloride	clonidine hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-602	clonidine hydrochloride	clonidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-602	clonidine hydrochloride	clonidine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1193	clonidine hydrochloride	clonidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1193	clonidine hydrochloride	clonidine hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1193	clonidine hydrochloride	clonidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1193	clonidine hydrochloride	clonidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1194	clonidine hydrochloride	clonidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1194	clonidine hydrochloride	clonidine hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1194	clonidine hydrochloride	clonidine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1194	clonidine hydrochloride	clonidine hydrochloride	Cadila Healthcare Limited	ANDA	Current