Application 212988

Type: ANDA
Sponsor: ESKAYEF

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	CAPSULE;ORAL	25MG	No	No
002	PREGABALIN	PREGABALIN	CAPSULE;ORAL	50MG	No	No
003	PREGABALIN	PREGABALIN	CAPSULE;ORAL	75MG	No	No
004	PREGABALIN	PREGABALIN	CAPSULE;ORAL	100MG	No	No
005	PREGABALIN	PREGABALIN	CAPSULE;ORAL	150MG	No	No
006	PREGABALIN	PREGABALIN	CAPSULE;ORAL	200MG	No	No
007	PREGABALIN	PREGABALIN	CAPSULE;ORAL	225MG	No	No
008	PREGABALIN	PREGABALIN	CAPSULE;ORAL	300MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212988-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08
A212988-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08
A212988-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08
A212988-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08
A212988-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08
A212988-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08
A212988-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08
A212988-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A212988-001	AB
A212988-002	AB
A212988-003	AB
A212988-004	AB
A212988-005	AB
A212988-006	AB
A212988-007	AB
A212988-008	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 7 · 248 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	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 248 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	A212988-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212988-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-008	AB	1	`b8a1b40f171c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	189b610e-3e29-42fa-ab6e-73effbe0d054	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
Pregabalin	PREGABALIN	Proficient Rx LP	34846423-e747-42c5-9bcd-f99c557c4f67	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	65d9e751-61c2-4741-85c0-2526cfdc765c	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988 ndc (product): 72658-0810 ndc (product): 72658-0814 ndc (product): 72658-0813 ndc (product): 72658-0812 ndc (product): 72658-0808 ndc (product): 72658-0811 ndc (product): 72658-0809 ndc (product): 72658-0849
Pregabalin	PREGABALIN	AvKARE	458705af-06fa-57d1-e063-6394a90a3b2e	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
Pregabalin	PREGABALIN	Westminster Pharmaceuticals, LLC	6b0ee2cf-52c3-4052-bea0-1458a4233745	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72658-0808	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0809	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0810	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0811	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0812	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0813	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0814	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
72658-0849	PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	ANDA	Current
75834-296	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-297	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-298	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-299	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-300	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-301	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-302	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-303	PREGABALIN	PREGABALIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current