Application 070317

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	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
A070317-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09
A070317-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09
A070317-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070317-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	1987-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070317-003	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	1987-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070317-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	1987-06-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A070317-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070317-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070317-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A070317-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070317-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070317-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070317-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070317-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070317-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070317-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070317-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070317-003	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 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e96ab74c-eedf-4d71-8a35-d5ec3daa7592	2026-07-21	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	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-06-10	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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0152	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0152	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0186	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0186	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0199	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0199	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
43063-190	Clonidine Hydrochloride	clonidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-190	Clonidine Hydrochloride	clonidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-190	Clonidine Hydrochloride	clonidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51079-299	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-299	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-299	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-300	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-300	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-300	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-301	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-301	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-301	Clonidine Hydrochloride	clonidine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51662-1515	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-094	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-094	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-094	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
53808-0228	Clonidine Hydrochloride	Clonidine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0230	Clonidine Hydrochloride	Clonidine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5561	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55154-5562	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55154-5570	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55154-6297	Clonidine Hydrochloride	Clonidine Hydrochloride	Cardinal Health	ANDA	Current
55289-073	Clonidine Hydrochloride	clonidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-074	Clonidine Hydrochloride	clonidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-970	Clonidine Hydrochloride	clonidine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
67046-098	Clonidine Hydrochloride	Clonidine Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
70518-1837	Clonidine Hydrochloride	clonidine hydrochloride	REMEDYREPACK INC.	ANDA	Current