Application 091219

Type: ANDA
Sponsor: TEVA PHARMS

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091219-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL			2019-07-19
A091219-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL			2019-07-19

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 · 84 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
2026-09-14 22:38:34	2026-08	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL		2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL		2019-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091219-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091219-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091219-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091219-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091219-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091219-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091219-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091219-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091219-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091219-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091219-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091219-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091219-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091219-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091219-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091219-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091219-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091219-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091219-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091219-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091219-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091219-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091219-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091219-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091219-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091219-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091219-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091219-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091219-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091219-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091219-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091219-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091219-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091219-002	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091219-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091219-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091219-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091219-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091219-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091219-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091219-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091219-002	AB	1	`a72a2bbeb626…`

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 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	38e80423-0194-4064-9447-abfd29fce1da	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	d2a98872-1a52-47e1-b4bd-0ff7d6272a92	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	27d02970-5f8b-4f4f-b89e-e42cc78ddaa3	2023-11-28	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7622	Pregabalin	Pregabalin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7622	Pregabalin	Pregabalin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7623	Pregabalin	Pregabalin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7623	Pregabalin	Pregabalin	Teva Pharmaceuticals USA, Inc.	ANDA	Current