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 8 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pregabalin	PREGABALIN	Dr.Reddys Laboratories Inc	ceed457b-8f43-4021-fd70-071c96e09470	2025-05-20	Warnings, Adverse reactions	Name fallback brand name: pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Cipla USA, Inc.	17a8087c-579f-42de-ae92-006ea64def2a	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	3fdc6e94-2504-416c-81dd-2db9bc194ebb	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Lyrica	PREGABALIN	Viatris Specialty LLC	d4734e7d-5079-455e-8ff5-8f4539c998a9	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
Pregabalin	PREGABALIN	Mylan Pharmaceuticals Inc.	ebe34db4-816d-4f0a-adbb-826693662754	2025-04-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b1f4b888-ac88-4250-8db1-706e7cc01e93	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b0f34220-0657-4868-ae01-014f9300f622	2025-03-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	580955ba-86f6-4e86-b0fa-dd44e8828b0e	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Coupler LLC	2ccc641e-6859-046e-e063-6294a90a5017	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Direct_Rx	8efb9652-86b9-4cb5-e053-2995a90adac0	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Direct_Rx	8ee9e08f-cf87-599c-e053-2995a90a563c	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Direct Rx	d88925b8-9be6-d862-e053-2995a90a1612	2025-01-21	Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Direct_Rx	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	8c3aedae-9745-4f63-ad64-a643f0245418	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	2b87989d-6411-4996-8f05-05806ab80525	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89ca3-5597-1c75-e053-2a95a90a3ff2	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afd59273-75d1-5f33-e053-2995a90ab25f	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc8d9f1-df31-607b-e053-2995a90a028c	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc8c76e-9b21-7ddb-e053-2a95a90ad736	2024-12-31	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.