Application 211687

Type: ANDA
Sponsor: ALVOGEN MALTA

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
A211687-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06
A211687-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06
A211687-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211687-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211687-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211687-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A211687-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211687-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211687-003	AB	1	`782e0a99824c…`

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 · 222 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	2026-07-01	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
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	REMEDYREPACK INC.	d095accf-9cea-4948-b43d-ae1b8fbce7c2	2026-06-11	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