Application 211685

Type: ANDA
Sponsor: APOTEX

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 43.

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	Approval date
A211685-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	2021-07-07
A211685-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	2021-07-07
A211685-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	2021-07-07
A211685-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	2021-07-07
A211685-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	2021-07-07
A211685-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	2021-07-07
A211685-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	2021-07-07
A211685-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	2021-07-07

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 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211685-001	PREGABALIN	25MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-002	PREGABALIN	50MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-003	PREGABALIN	75MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-004	PREGABALIN	100MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-005	PREGABALIN	150MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-006	PREGABALIN	200MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-007	PREGABALIN	225MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211685-008	PREGABALIN	300MG	CAPSULE / ORAL	2021-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211685-001	PREGABALIN	25MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-002	PREGABALIN	50MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-003	PREGABALIN	75MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-004	PREGABALIN	100MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-005	PREGABALIN	150MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-006	PREGABALIN	200MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-007	PREGABALIN	225MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211685-008	PREGABALIN	300MG	CAPSULE / ORAL	2021-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211685-001	PREGABALIN	25MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-002	PREGABALIN	50MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-003	PREGABALIN	75MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-004	PREGABALIN	100MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-005	PREGABALIN	150MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-006	PREGABALIN	200MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-007	PREGABALIN	225MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211685-008	PREGABALIN	300MG	CAPSULE / ORAL	2021-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-001	PREGABALIN	25MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-002	PREGABALIN	50MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-003	PREGABALIN	75MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-004	PREGABALIN	100MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-005	PREGABALIN	150MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-006	PREGABALIN	200MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-007	PREGABALIN	225MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211685-008	PREGABALIN	300MG	CAPSULE / ORAL	2021-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211685-001	PREGABALIN	25MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-002	PREGABALIN	50MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-003	PREGABALIN	75MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-004	PREGABALIN	100MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-005	PREGABALIN	150MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-006	PREGABALIN	200MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-007	PREGABALIN	225MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211685-008	PREGABALIN	300MG	CAPSULE / ORAL	2021-07-07	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 232 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211685-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211685-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211685-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-006	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-007	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211685-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-006	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-007	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211685-008	AB	1	`5bbf6a4d5a75…`

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 12 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	d58c0808-2ff9-4ce6-9c07-56f723592385	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a0f2b8af-0a04-4db0-adb3-d9d9369223d9	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Asclemed USA, Inc.	69b8a843-a3a8-4d76-8418-f48288625030	2020-06-25	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	60185c88-ecfd-46f9-adb9-b97c6b00a553	2020-06-15	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
PREGABALIN	PREGABALIN	Proficient Rx LP	4624c58f-8f77-48fa-be0f-fca4010cc8ae	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Proficient Rx LP	6022939f-92a8-4cb4-9f04-f237a4d73f6f	2019-10-01	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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-3793	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3794	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3795	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3796	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3797	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3798	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3799	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current
60505-3800	Pregabalin	Pregabalin	ApotexCorp	ANDA	Current