Application 091040

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	CAPSULE;ORAL	25MG	No	No
002	PREGABALIN	PREGABALIN	CAPSULE;ORAL	50MG	No	No
003	PREGABALIN	PREGABALIN	CAPSULE;ORAL	75MG	No	No
004	PREGABALIN	PREGABALIN	CAPSULE;ORAL	100MG	No	No
005	PREGABALIN	PREGABALIN	CAPSULE;ORAL	150MG	No	No
006	PREGABALIN	PREGABALIN	CAPSULE;ORAL	200MG	No	No
007	PREGABALIN	PREGABALIN	CAPSULE;ORAL	225MG	No	No
008	PREGABALIN	PREGABALIN	CAPSULE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091040-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	2022-05-03
A091040-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	2022-05-03
A091040-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	2022-05-03
A091040-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	2022-05-03
A091040-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	2022-05-03
A091040-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	2022-05-03
A091040-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	2022-05-03
A091040-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	2022-05-03

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 7 · 256 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091040-001	PREGABALIN	25MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-002	PREGABALIN	50MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-003	PREGABALIN	75MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-004	PREGABALIN	100MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-005	PREGABALIN	150MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-006	PREGABALIN	200MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-007	PREGABALIN	225MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091040-008	PREGABALIN	300MG	CAPSULE / ORAL	2022-05-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091040-001	PREGABALIN	25MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-002	PREGABALIN	50MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-003	PREGABALIN	75MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-004	PREGABALIN	100MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-005	PREGABALIN	150MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-006	PREGABALIN	200MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-007	PREGABALIN	225MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091040-008	PREGABALIN	300MG	CAPSULE / ORAL	2022-05-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091040-001	PREGABALIN	25MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-002	PREGABALIN	50MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-003	PREGABALIN	75MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-004	PREGABALIN	100MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-005	PREGABALIN	150MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-006	PREGABALIN	200MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-007	PREGABALIN	225MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091040-008	PREGABALIN	300MG	CAPSULE / ORAL	2022-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091040-001	PREGABALIN	25MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-002	PREGABALIN	50MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-003	PREGABALIN	75MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-004	PREGABALIN	100MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-005	PREGABALIN	150MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-006	PREGABALIN	200MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-007	PREGABALIN	225MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091040-008	PREGABALIN	300MG	CAPSULE / ORAL	2022-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-001	PREGABALIN	25MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-002	PREGABALIN	50MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-003	PREGABALIN	75MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-004	PREGABALIN	100MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-005	PREGABALIN	150MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-006	PREGABALIN	200MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-007	PREGABALIN	225MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091040-008	PREGABALIN	300MG	CAPSULE / ORAL	2022-05-03	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-007	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091040-008	AB	1	`5c6f7cd8ea54…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-005	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-006	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-007	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091040-008	AB	1	`cb3db0bc1861…`

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 11 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	137ffe30-ff8b-409d-a719-6be19d4d9522	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a17f03ea-9375-48fe-be32-f8df509f5fba	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Alembic Pharmaceuticals Limited	78a36538-701d-4dd9-a7fc-87d505784c83	2023-05-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	1d76c6a3-7899-4dec-afcc-2b575dfa6c25	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	920c57e0-ddfe-4750-b353-5f96b65443cf	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Tris Pharma Inc	62aa850d-199c-44d5-a730-45f43efa850e	2022-11-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	df80e09f-3d57-47a0-ba58-bb79e9ba1953	2022-11-29	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Asclemed USA, Inc.	3d2464fb-b3ac-496e-b8a5-c2e8a902ce29	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin Extended Release	PREGABALIN	ScieGen Pharmaceuticals, INC.	1544a657-353c-47f8-96ac-a63fa78373f0	2022-09-19	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	65311ae9-e440-4650-b1b1-6f4495fda93c	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	c7986739-3fc9-4a1d-8dd6-2e11cf1f3610	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	68829d7b-ab40-429e-92dc-91f8a0d49afd	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Patrin Pharma, Inc.	d92c94e5-e542-4177-afa8-fa00ba17634c	2022-06-21	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a1545bbb-b337-4760-ab4c-fb76ab019337	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	1503dd3b-688b-4702-8fc1-954b5ffe4235	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	9b1472ac-8b79-4f22-ae50-3b0942bd62b1	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	d58c0808-2ff9-4ce6-9c07-56f723592385	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a0f2b8af-0a04-4db0-adb3-d9d9369223d9	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Asclemed USA, Inc.	69b8a843-a3a8-4d76-8418-f48288625030	2020-06-25	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.