Application 206222

Type: ANDA
Sponsor: IPCA LABS 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	Approval date
A206222-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	2023-12-29
A206222-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	2023-12-29
A206222-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	2023-12-29

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 2 · 57 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	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL		2023-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL		2023-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL		2023-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2023-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2023-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2023-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2023-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2023-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2023-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2023-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2023-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2023-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2023-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2023-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2023-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2023-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206222-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2023-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206222-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2023-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206222-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2023-12-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206222-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206222-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206222-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206222-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206222-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206222-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206222-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206222-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206222-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206222-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206222-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206222-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206222-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206222-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206222-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206222-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206222-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206222-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206222-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206222-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206222-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206222-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206222-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206222-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206222-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206222-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206222-003	AB	1	`1c564ffb4f44…`

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 2 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	bb972d36-4b2c-45ae-8504-3a16d352dd8b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	f6022b2f-9b43-40cc-91c7-c224b209efab	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Camber Pharmaceuticals, Inc.	00fc3250-3e29-4a4b-ac0c-74910659337c	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Asclemed USA, Inc.	10175591-c1b4-461a-830e-8df982d0d2bf	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	be25bb4e-d84f-4396-a78f-a668a207cf2d	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	DIRECT RX	a7bd3e3c-26e9-07e7-e053-2995a90a9ca5	2025-01-17	Boxed warning, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
Lunesta	ESZOPICLONE	Waylis Therapeutics LLC	3821f4b7-a3c8-4920-ba80-18aa96532c09	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571a-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af863d89-25db-2893-e053-2a95a90a704c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86ebdb-e47b-706a-e053-2995a90ad51c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af869866-0a11-1a05-e053-2a95a90acdb8	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86b753-d2ee-9b5f-e053-2a95a90ad23d	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	af86fca8-571e-0cac-e053-2a95a90ae402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	b39dc64d-adc9-742e-e053-2a95a90ad18b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx Pharmacy of Tennessee, LLC	b4f272eb-02e3-415a-e053-2a95a90a428f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Advanced Rx Pharmacy of Tennessee, LLC	c8ae09eb-4c9b-4560-e053-2995a90a02b1	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Dr. Reddy's Laboratories Limited	0b363b90-93dc-1fc1-0501-d140dfc762c7	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Quality Care Products LLC	3b8a09c6-0702-43a7-b47f-a36cd00b7584	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Quality Care Products LLC	7832f554-2b82-4ef2-b1ef-266179f271d3	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	d1baa5ba-73ac-462b-a728-217d5992674a	2024-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE

Reported adverse events (FAERS/openFDA)#

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