Application 209357

Type: ANDA
Sponsor: MSN

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
A209357-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A209357-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A209357-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A209357-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A209357-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A209357-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A209357-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A209357-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209357-001	AB
A209357-002	AB
A209357-003	AB
A209357-004	AB
A209357-005	AB
A209357-006	AB
A209357-007	AB
A209357-008	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 9 · 336 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	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	A209357-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209357-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209357-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209357-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-008	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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	REMEDYREPACK INC.	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	326c643a-23c5-4dab-9266-abc22ca1f874	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	91edbe87-cd22-43a5-9952-1cd523b13820	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	14f3f9ba-7a4a-45d5-a25e-efe5cdff117d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	44ec2918-4e0c-4e2d-9157-81295a15df57	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	36c3dda1-67fb-4dc5-e063-6294a90a1c3e	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	2e6e6f9c-a14c-2d75-e063-6294a90a827e	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	ba3006b7-991f-4ae0-b908-5910e827e5bf	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	5290f7ad-6660-45ff-853d-6dcb947b570d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	4b94bfc1-88fc-2b5f-e063-6394a90a7077	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	217c9f93-fe89-4684-8553-12ec9acaa507	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	5d33e9c7-6d81-485b-bf4a-9a588eda5208	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	fa24fa02-e27d-476a-b6c4-93650aaaee68	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89689-bea9-92ec-e053-2995a90a7f21	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357 ndc (product): 80425-0030
Pregabalin	PREGABALIN	AvPAK	40c0f658-2a0a-034b-e063-6394a90a1097	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Proficient Rx LP	7d25bec8-b503-4f63-8995-372a6df58c72	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Novadoz Pharmaceuticals LLC	193666f7-3c55-43b1-947a-2ffec40c687f	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b1f4b888-ac88-4250-8db1-706e7cc01e93	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b0f34220-0657-4868-ae01-014f9300f622	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Proficient Rx LP	580955ba-86f6-4e86-b0fa-dd44e8828b0e	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357

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 2 of 2 · 82 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80425-0030	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0030	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current