Application 211593

Type: ANDA
Sponsor: ALVOGEN PINE BROOK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	82.5MG	No	No
002	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	165MG	No	No
003	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	330MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A211593-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-04-13
A211593-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-04-13
A211593-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-04-13

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 · 99 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
2026-02-19 14:30 UTC	2026-02	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211593-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211593-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211593-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211593-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211593-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211593-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211593-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211593-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211593-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211593-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211593-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211593-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211593-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211593-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211593-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211593-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211593-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211593-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211593-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211593-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211593-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211593-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211593-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211593-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211593-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211593-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211593-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211593-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211593-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211593-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211593-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211593-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211593-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211593-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211593-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211593-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211593-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211593-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211593-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211593-001	AB	1	`bb7c543d1eb4…`

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 3 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.	efe06a26-30c5-437d-9fd1-4bd0062f1200	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Amneal Pharmaceuticals NY LLC	3d9d7123-5886-4b61-a7ea-471b213e77d9	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	12309847-0857-4ff7-a7e7-edeadc3dfb61	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	1a8d8292-1f94-46da-bade-8c4054201343	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	b977269a-7d62-44a2-bd0d-11c54b872836	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	fd01590e-5b90-4a77-ad5f-76adabf3c32e	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4d63908b-96be-554c-e063-6394a90af510	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	8a7acea4-108d-40d2-a2a7-36088be97248	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	025c3adb-5f6b-45f5-a4c6-cea8e57102e3	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	2ceccc4d-97e2-4eb0-841f-23609187710c	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	247aedca-ae27-44c6-b32c-c95d26454566	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	e1ed81bc-1597-4bc5-80cd-09977a154e4b	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	fd568ede-dac7-4910-bb18-65fb00f2636e	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	32789571-a566-46fa-ba41-bd3c86276ecf	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	3dd7930b-f544-f18b-e063-6294a90a0541	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	c60f6b1e-7a24-41b2-8435-e20583a732c6	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	52e36f66-4c4a-4fc5-968b-46879b7bf1db	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	df382975-73f1-4957-8959-177848f796f7	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	90b65884-4222-4011-b042-88b83e51c57a	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	dbf3647a-5ab1-450e-be5f-69b844185572	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-379	Pregabalin Extended Release	PREGABALIN	Alvogen Inc.	ANDA	Current
47781-379	Pregabalin Extended Release	PREGABALIN	Alvogen Inc.	ANDA	Current
47781-380	Pregabalin Extended Release	PREGABALIN	Alvogen Inc.	ANDA	Current
47781-380	Pregabalin Extended Release	PREGABALIN	Alvogen Inc.	ANDA	Current
47781-381	Pregabalin Extended Release	PREGABALIN	Alvogen Inc.	ANDA	Current
47781-381	Pregabalin Extended Release	PREGABALIN	Alvogen Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67402	ORIG	2021-05-05