Application 215249

Type: ANDA
Sponsor: RUBICON

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	TE codes	Approval date
A215249-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22
A215249-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22
A215249-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215249-001	AB
A215249-002	AB
A215249-003	AB

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 · 90 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	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215249-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215249-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215249-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215249-001	AB	1	`8072bd15b7f6…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Advagen Pharma Ltd.	2ffee7e7-bfa0-4933-9baf-7df55080816e	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215249 application number: ANDA215249 ndc (product): 72888-050 ndc (product): 72888-049 ndc (product): 72888-051

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-049	Pregabalin	Pregabalin	Advagen Pharma Ltd.	ANDA	Current
72888-050	Pregabalin	Pregabalin	Advagen Pharma Ltd.	ANDA	Current
72888-051	Pregabalin	Pregabalin	Advagen Pharma Ltd.	ANDA	Current