Application 215577

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	82.5MG	No	No
002	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	165MG	No	No
003	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	330MG	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
A215577-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26
A215577-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26
A215577-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26

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 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215577-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215577-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215577-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-08-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A215577-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215577-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215577-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215577-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215577-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215577-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215577-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215577-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215577-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215577-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215577-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215577-003	AB	1	`e64feba35796…`

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 7 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3e9cfeb9-1e2b-ea79-e063-6394a90a67b1	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	e8e272a4-c181-4573-822b-2bb315b6ad37	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Cadila Pharmaceuticals Limited	170c0c95-2ee8-4dff-bbd6-b87a21e8cf81	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	ceedde96-fdaf-4708-9ca1-e48e052cde75	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	a0da0534-b386-4c93-ae89-03b0e3325e02	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	1760ccdc-46f7-4182-a563-96b13212cb7e	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	3dbfd868-8408-4514-ba1c-04a5d095c16a	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	31e7caf6-0a8b-f343-e063-6294a90ad729	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Rising Pharma Holdings, Inc.	dbebfa61-0685-41b4-8364-00b8d8b73714	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Novadoz Pharmaceuticals LLC	193666f7-3c55-43b1-947a-2ffec40c687f	2025-08-28	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
pregabalin	PREGABALIN	Indoco Remedies Limited	0a8d9e35-46fd-4c70-bb7f-4e8b754f2794	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3c6daa12-5284-d9f1-e063-6294a90ae060	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Alembic Pharmaceuticals Inc.	cf7b4b67-b017-47ac-af3f-bde5bd07bb0c	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3ab4efb3-1ae5-2504-e063-6294a90a6d1d	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3ab57054-02c2-5e28-e063-6294a90a71ab	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3a124f59-38c2-7280-e063-6394a90a43b4	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3a1374f4-79dd-ebbc-e063-6394a90a53b0	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ef7c2e2c-c314-4bfd-a9fa-39f0b0884d34	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Amneal Pharmaceuticals NY LLC	3099759f-cb24-40e8-b482-9388c38c73b9	2025-06-19	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	MARKSANS PHARMA LIMITED	b2b81bb6-5423-4221-8a61-f70a38d6a1e9	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

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