Application 202929

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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 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	TE codes	Approval date
A202929-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30
A202929-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30
A202929-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202929-001	AB
A202929-002	AB
A202929-003	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 · 129 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	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202929-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202929-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202929-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202929-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202929-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202929-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202929-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202929-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202929-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202929-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202929-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202929-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202929-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202929-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202929-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202929-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202929-001	AB	1	`301d65b070ca…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	REMEDYREPACK INC.	9dfe774a-2c7a-4e10-bedd-cde64ad28676	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	2b5b4fbb-9b86-46c6-9508-37d3d9806dec	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	REMEDYREPACK INC.	61fd4655-060f-4393-a610-019d8b127058	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	abe3a610-a25d-4b52-8537-c87e8ba3104a	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
ESZOPICLONE	ESZOPICLONE	DIRECT RX	486b760b-7fea-306b-e054-00144ff8d46c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	f6022b2f-9b43-40cc-91c7-c224b209efab	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Asclemed USA, Inc.	10175591-c1b4-461a-830e-8df982d0d2bf	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929 ndc (product): 76420-027
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	be25bb4e-d84f-4396-a78f-a668a207cf2d	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571a-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929 ndc (product): 80425-0062
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af863d89-25db-2893-e053-2a95a90a704c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929 ndc (product): 80425-0065
Eszopiclone	ESZOPICLONE	Advanced Rx Pharmacy of Tennessee, LLC	c8ae09eb-4c9b-4560-e053-2995a90a02b1	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929 ndc (product): 80425-0168
Eszopiclone	ESZOPICLONE	Quality Care Products LLC	3b8a09c6-0702-43a7-b47f-a36cd00b7584	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Quality Care Products LLC	7832f554-2b82-4ef2-b1ef-266179f271d3	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	9a891ab1-675f-498e-a21e-05964307d2dd	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	NuCarePharmaceuticals, Inc.	53fcee89-027a-13e5-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Proficient Rx LP	d301b0cf-1492-4be9-83a0-1b64c8fa3b72	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Macleods Pharmaceuticals Limited	12593790-e72f-45b1-8895-987cdd075134	2022-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Proficient Rx LP	5451be60-1315-4152-ad13-412e86903c8a	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929
Eszopiclone	ESZOPICLONE	Proficient Rx LP	1582ba77-a4e3-464f-876b-28cc7e41e8f1	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202929 application number: ANDA202929

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 2 of 2 · 92 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76420-027	Eszopiclone	Eszopiclone	Asclemed USA, Inc.	ANDA	Current
80425-0062	Lunesta	Eszopiclone 2mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0062	Lunesta	Eszopiclone 2mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0062	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0062	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0065	Lunesta	Eszopiclone 3mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0065	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0065	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0065	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0168	Lunesta	Eszopiclone 1mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0168	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0168	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current