Application 210585

Type: ANDA
Sponsor: CSPC OUYI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	CAPSULE;ORAL	50MG	No	No
002	PREGABALIN	PREGABALIN	CAPSULE;ORAL	75MG	No	No
003	PREGABALIN	PREGABALIN	CAPSULE;ORAL	100MG	No	No
004	PREGABALIN	PREGABALIN	CAPSULE;ORAL	150MG	No	No
005	PREGABALIN	PREGABALIN	CAPSULE;ORAL	200MG	No	No
006	PREGABALIN	PREGABALIN	CAPSULE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210585-001	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26
A210585-002	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26
A210585-003	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26
A210585-004	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26
A210585-005	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26
A210585-006	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A210585-001	AB
A210585-002	AB
A210585-003	AB
A210585-004	AB
A210585-005	AB
A210585-006	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 6 · 228 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
2026-08-18 06:07:40	2026-07	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-005	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-005	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-005	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-005	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-005	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-005	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-001	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-002	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-003	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-004	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-12-26	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210585-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210585-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210585-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210585-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210585-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210585-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210585-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210585-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210585-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210585-004	AB	1	`03ed91905a0d…`

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 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	7f29991e-3bf5-4e48-8fa3-6d4e932ed6de	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	ce1419bc-c348-4407-b320-e0598d5a7b19	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	d095accf-9cea-4948-b43d-ae1b8fbce7c2	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	12309847-0857-4ff7-a7e7-edeadc3dfb61	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	47d08b8f-a24d-4159-ab43-2eb67a93559b	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	3c8ea6da-5771-4096-a915-700e51ced05c	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	9c38abbc-2b3d-48d6-b629-4a163c803db5	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	efe06a26-30c5-437d-9fd1-4bd0062f1200	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	326c643a-23c5-4dab-9266-abc22ca1f874	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	5d738807-7f88-4943-9c3b-01f1e52ea72d	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Ascend Laboratories, LLC	e48db3c2-7351-41f2-a451-5a8341c4125c	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	9685792b-911d-4cf9-9881-d21abca48c66	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	c60752f8-20d5-4333-bf33-a656eab01d6b	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	0f72ec70-314c-4c9f-86be-54f3e010356d	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	91edbe87-cd22-43a5-9952-1cd523b13820	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	14f3f9ba-7a4a-45d5-a25e-efe5cdff117d	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	44ec2918-4e0c-4e2d-9157-81295a15df57	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	1e6fa742-f658-495f-88bb-8eddf9a45ffe	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	48798c13-3ef4-4e7f-9f73-92dccac0af14	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN