Application 205321

Type: ANDA
Sponsor: AUROBINDO PHARMA USA

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	TE codes	Approval date
A205321-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2023-03-29
A205321-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2023-03-29
A205321-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2023-03-29
A205321-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2023-03-29
A205321-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2023-03-29
A205321-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2023-03-29
A205321-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2023-03-29
A205321-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2023-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205321-001	AB
A205321-002	AB
A205321-003	AB
A205321-004	AB
A205321-005	AB
A205321-006	AB
A205321-007	AB
A205321-008	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 5 · 200 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	A205321-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2023-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205321-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2023-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205321-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2023-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2023-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205321-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2023-03-29	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205321-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205321-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205321-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205321-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205321-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205321-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205321-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205321-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205321-008	AB	1	`6a471c1ec25d…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Clinical Solutions Wholesale, LLC	93c2fe8b-67d7-4a15-8790-5595e158b3ab	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205321 application number: ANDA205321
Pregabalin	PREGABALIN	Coupler LLC	5383c0de-0c85-f702-e063-6294a90a1d8d	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205321 application number: ANDA205321
Pregabalin	PREGABALIN	Aurobindo Pharma Limited	11034861-eef2-4996-8082-afc3c1769171	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205321 application number: ANDA205321
Pregabalin	PREGABALIN	Coupler LLC	463d31dd-ff14-cc89-e063-6294a90a2ea9	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205321 application number: ANDA205321
Pregabalin	PREGABALIN	Coupler LLC	2ccc641e-6859-046e-e063-6294a90a5017	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205321 application number: ANDA205321
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	29b91992-c853-a57d-e063-6394a90ab365	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205321 application number: ANDA205321

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.