Application 091228

Type: ANDA
Sponsor: MYLAN

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 43.

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
A091228-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	2019-09-20
A091228-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	2019-09-20
A091228-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	2019-09-20
A091228-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	2019-09-20
A091228-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	2019-09-20
A091228-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	2019-09-20
A091228-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	2019-09-20
A091228-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	2019-09-20

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 9 · 328 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	A091228-001	PREGABALIN	25MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-002	PREGABALIN	50MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-003	PREGABALIN	75MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-004	PREGABALIN	100MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-005	PREGABALIN	150MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-006	PREGABALIN	200MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-007	PREGABALIN	225MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091228-008	PREGABALIN	300MG	CAPSULE / ORAL	2019-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091228-001	PREGABALIN	25MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-002	PREGABALIN	50MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-003	PREGABALIN	75MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-004	PREGABALIN	100MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-005	PREGABALIN	150MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-006	PREGABALIN	200MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-007	PREGABALIN	225MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091228-008	PREGABALIN	300MG	CAPSULE / ORAL	2019-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091228-001	PREGABALIN	25MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-002	PREGABALIN	50MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-003	PREGABALIN	75MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-004	PREGABALIN	100MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-005	PREGABALIN	150MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-006	PREGABALIN	200MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-007	PREGABALIN	225MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091228-008	PREGABALIN	300MG	CAPSULE / ORAL	2019-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-001	PREGABALIN	25MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-002	PREGABALIN	50MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-003	PREGABALIN	75MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-004	PREGABALIN	100MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-005	PREGABALIN	150MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-006	PREGABALIN	200MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-007	PREGABALIN	225MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091228-008	PREGABALIN	300MG	CAPSULE / ORAL	2019-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091228-001	PREGABALIN	25MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-002	PREGABALIN	50MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-003	PREGABALIN	75MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-004	PREGABALIN	100MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-005	PREGABALIN	150MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-006	PREGABALIN	200MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-007	PREGABALIN	225MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091228-008	PREGABALIN	300MG	CAPSULE / ORAL	2019-09-20	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-007	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091228-008	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091228-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-006	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-007	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091228-008	AB	1	`3f01610625f2…`

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 6 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	14c00449-c3b8-d6ba-e063-6294a90ab627	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	ScieGen Pharmaceuticals, Inc	33ef1a3b-554f-4a51-afdb-92a019e8c16c	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Creekwood Pharmaceuticals LLC	bfe4108e-b2d2-4059-be16-21d3276c3ae4	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	AvPAK	40c0f658-2a0a-034b-e063-6394a90a1097	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	bf710bcf-75ed-4184-b9c3-81cd05a780a4	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	b5b22ec1-3fd8-4631-ba7e-98d8e5d030b3	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Westminster Pharmaceuticals, LLC	781cb1ac-a0d2-4b47-b319-f0b90de86384	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	7d25bec8-b503-4f63-8995-372a6df58c72	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	3ce4dfdf-e32f-40e8-9a13-e45d51539e08	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Camber Pharmaceuticals, Inc.	241c4b7e-f719-4828-8639-ea613b8a6583	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	ca861bfb-caef-4764-bad5-c95a0d035475	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	0101cd1f-4a95-40e9-86a8-ccde8d656e3d	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	311e748a-7db4-4967-989b-5ed96871d99a	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	ff55a40e-4a5a-40db-87b1-7ece1d5b316f	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	72832f05-325e-4a72-8a33-da114e39c52d	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3f002a7f-e632-e58f-e063-6394a90abce8	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	3f00c179-336d-e534-e063-6294a90a9141	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	8ac0689e-47a3-44d7-bf98-a919c302726d	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	dc50f01d-1802-4666-8f2f-35980a40990f	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	25345672-1368-4e3a-95b2-ca45fe120294	2025-09-12	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.