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 1 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.	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	326c643a-23c5-4dab-9266-abc22ca1f874	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	5d738807-7f88-4943-9c3b-01f1e52ea72d	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Ascend Laboratories, LLC	e48db3c2-7351-41f2-a451-5a8341c4125c	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	9685792b-911d-4cf9-9881-d21abca48c66	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	c60752f8-20d5-4333-bf33-a656eab01d6b	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	0f72ec70-314c-4c9f-86be-54f3e010356d	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
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	2026-07-01	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

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