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 43.

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 · 105 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	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211593-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211593-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211593-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
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…`

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 9 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	af739a0d-a3cd-754f-e053-2a95a90ad655	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d28168cd-9b7a-f8df-e053-2995a90ad97f	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b8172d6b-a646-e559-e053-2a95a90ac24d	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	bc1b143d-feaf-9498-e053-2995a90acf50	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b817083c-b535-2269-e053-2a95a90af5b9	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c6b456ca-9d07-7789-e053-2a95a90a20c5	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8bfc4f9-6208-4eaa-e053-2a95a90ada97	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8acdbcf-3076-63b2-e053-2a95a90aa3c4	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c89a3514-f637-e54f-e053-2a95a90a6881	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d2804923-a466-6dc6-e053-2a95a90a4182	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f5d9b625-783c-bd78-e053-2995a90a37d2	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f8ae62be-3a68-be6b-e053-6394a90ab627	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	29b91992-c853-a57d-e063-6394a90ab365	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Quality Care Products, LLC	59432752-c8d8-4396-95dd-0e04c55bc82b	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Quality Care Products, LLC	1e087436-0534-4de2-b310-a5cc0e46adbd	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Quality Care Products, LLC	ff386af0-17d3-4f95-803b-b51cb79e5295	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d2813712-d7f6-6144-e053-2995a90a3c5d	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	4cda70e8-9ae1-4958-8c86-1bc633be982b	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	cf7f0fd0-bac2-4836-9363-79d32ad0cc10	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	08ad87e3-e00c-46d1-98f8-df493cf1712e	2024-09-06	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 · 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