Application 091113

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	1MG	No	No
002	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	2MG	No	No
003	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	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
A091113-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10
A091113-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10
A091113-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091113-001	AB
A091113-002	AB
A091113-003	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	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2014-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2014-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091113-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2014-06-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091113-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091113-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091113-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091113-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091113-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091113-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091113-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091113-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091113-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091113-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091113-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091113-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091113-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091113-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091113-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091113-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091113-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	Bionpharma Inc.	ec6ac172-509e-403a-aa0d-4c60010a0035	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091113 application number: ANDA091113 ndc (product): 69452-349 ndc (product): 69452-348 ndc (product): 69452-347

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-320	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-320	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-320	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-320	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-321	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-321	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-321	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-321	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-322	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-322	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-322	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
42043-322	ESZOPICLONE	ESZOPICLONE	OrchidPharma Inc	ANDA	Current
50436-0320	ESZOPICLONE	ESZOPICLONE	Unit Dose Services	ANDA	Current
50436-0322	ESZOPICLONE	ESZOPICLONE	Unit Dose Services	ANDA	Current
53217-149	ESZOPICLONE	ESZOPICLONE	Aidarex Pharmaceuticals LLC	ANDA	Current
61919-323	ESZOPICLONE	ESZOPICLONE	DirectRX	ANDA	Current
61919-514	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
61919-514	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
61919-587	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
61919-587	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
63187-579	ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	ANDA	Current
63187-579	ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	ANDA	Current
63187-665	ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	ANDA	Current
63187-665	ESZOPICLONE	ESZOPICLONE	Proficient Rx LP	ANDA	Current
68788-8953	ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9315	ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	ANDA	Current
69452-347	ESZOPICLONE	ESZOPICLONE	Bionpharma Inc.	ANDA	Current
69452-348	ESZOPICLONE	ESZOPICLONE	Bionpharma Inc.	ANDA	Current
69452-349	ESZOPICLONE	ESZOPICLONE	Bionpharma Inc.	ANDA	Current
71335-0005	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0005	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0005	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0005	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0148	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0148	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0148	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-0148	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-1794	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-1794	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
71335-1794	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current