Application 070886

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	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	TE codes	Approval date
A070886-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31
A070886-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31
A070886-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A070886-001	AB
A070886-002	AB
A070886-003	AB

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	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070886-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070886-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070886-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070886-001	AB	1	`8072bd15b7f6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	b359baee-6faf-4f7d-be86-ba7a1b1de770	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	0906c25f-e5b8-4a08-9b10-d1f06419e275	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	c8e151d6-50c6-47a1-80b0-bd8e07acddd2	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	c7f473df-94ab-41db-8cc7-9a159d5e6dc4	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Aurobindo Pharma Limited	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	2022-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886 ndc (product): 59651-234 ndc (product): 59651-233 ndc (product): 59651-232

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-232	Clonidine Hydrochloride	Clonidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-233	Clonidine Hydrochloride	Clonidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-234	Clonidine Hydrochloride	Clonidine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current