Application 211889

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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 43.

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	Approval date
A211889-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2021-04-13
A211889-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2021-04-13
A211889-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2021-04-13

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 · 105 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	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211889-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211889-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211889-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211889-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211889-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211889-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211889-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211889-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211889-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211889-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211889-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211889-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211889-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211889-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211889-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211889-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211889-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211889-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211889-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211889-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211889-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211889-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211889-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211889-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211889-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211889-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211889-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211889-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211889-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211889-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211889-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211889-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211889-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211889-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211889-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211889-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211889-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211889-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211889-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211889-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211889-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211889-003	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211889-001	AB	1	`6a51e52b5d6a…`

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 5 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Clinical Solutions Wholesale, LLC	613a7a13-d5ba-4827-91ec-3ed5176602b7	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	REMEDYREPACK INC.	1a8f13f6-0f4c-4194-ba37-b2d1a8fc4993	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	A-S Medication Solutions	54a9bfb4-dcff-491d-9676-1fe1d05e004c	2026-02-08	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	A-S Medication Solutions	217c9f93-fe89-4684-8553-12ec9acaa507	2026-02-08	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	A-S Medication Solutions	5d33e9c7-6d81-485b-bf4a-9a588eda5208	2026-02-08	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	A-S Medication Solutions	fa24fa02-e27d-476a-b6c4-93650aaaee68	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	A-S Medication Solutions	55b62778-0e6a-45e8-9ace-3f1d6eca4487	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	99c3d252-4d51-4679-aa61-e2d0b8238b38	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advagen Pharma Ltd.	2ffee7e7-bfa0-4933-9baf-7df55080816e	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Coupler LLC	463d31dd-ff14-cc89-e063-6294a90a2ea9	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Major Pharmaceuticals	2420e2d7-c01a-4590-88c5-6fe5361747e9	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	65d9e751-61c2-4741-85c0-2526cfdc765c	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Ascend Laboratories, LLC	1b731dd5-b000-4c38-bfc8-2505b076e316	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Golden State Medical Supply, Inc.	1ef735e8-467e-ed0d-e063-6294a90a210e	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	NorthStar RxLLC	4a4d4c76-31c5-413b-be7c-82cb8091c19d	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	ScieGen Pharmaceuticals, Inc	459f0d31-a73f-2c62-e063-6394a90a810c	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89689-bea9-92ec-e053-2995a90a7f21	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Chartwell RX, LLC	13d03119-e49b-482e-b5f9-d40dc3f4862e	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	335e3bcb-10a3-481b-ad95-ee9ceaa3689e	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Westminster Pharmaceuticals, LLC	6b0ee2cf-52c3-4052-bea0-1458a4233745	2025-10-31	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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-047	Pregabalin	Pregabalin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-047	Pregabalin	Pregabalin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-048	Pregabalin	Pregabalin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-048	Pregabalin	Pregabalin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-049	Pregabalin	Pregabalin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-049	Pregabalin	Pregabalin	Sun Pharmaceutical Industries, Inc.	ANDA	Current