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 2 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
PREGABALIN	PREGABALIN	Cardinal Health 107, LLC	124176c7-d8ab-4bbe-b468-3e5d12f03e44	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	fc5dd378-950f-949b-e053-6394a90a3ca2	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	9235cd08-7a25-4b81-e053-2995a90a539c	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	189b610e-3e29-42fa-ab6e-73effbe0d054	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	35d3486c-c6ea-4d31-e063-6294a90a1219	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	35d387dd-bc7f-37a4-e063-6394a90abbbb	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	36c3dda1-67fb-4dc5-e063-6294a90a1c3e	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	2c62e63a-fe81-a463-e063-6394a90a65ee	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	2e6e6f9c-a14c-2d75-e063-6294a90a827e	2026-06-20	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	ba3006b7-991f-4ae0-b908-5910e827e5bf	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Clinical Solutions Wholesale, LLC	150c8b71-98b0-4c6b-b20f-fd0fca2d3c26	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Novadoz Pharmaceuticals LLC	f6aa5977-97c8-4a56-8e35-d9ab5cc24369	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Coupler LLC	5383c0de-0c85-f702-e063-6294a90a1d8d	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	923743f0-f557-9143-e053-2a95a90a21ae	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	A-S Medication Solutions	b740832a-6e90-4b20-bfed-be0415f1aebe	2026-06-03	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