Application 213313

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	165MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213313-001	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL			2021-04-13
A213313-002	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 2 · 70 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	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL		2021-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213313-001	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213313-002	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213313-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213313-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213313-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213313-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213313-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213313-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213313-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213313-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213313-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213313-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213313-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213313-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213313-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213313-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213313-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213313-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213313-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213313-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213313-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213313-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213313-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213313-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213313-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213313-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213313-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213313-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213313-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213313-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213313-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213313-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213313-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213313-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213313-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213313-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213313-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213313-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213313-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213313-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213313-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213313-002	AB	1	`a67488948f0b…`

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 12 · 227 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	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	e897d7e8-2743-4512-8417-375cb11ceec6	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	84bf3abb-559d-4140-a689-f3e26b1c4ff2	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	923745e9-17a2-a5f7-e053-2a95a90aed38	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	7f29991e-3bf5-4e48-8fa3-6d4e932ed6de	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Preferred Pharmaceuticals, Inc.	ce1419bc-c348-4407-b320-e0598d5a7b19	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	d095accf-9cea-4948-b43d-ae1b8fbce7c2	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	12309847-0857-4ff7-a7e7-edeadc3dfb61	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	47d08b8f-a24d-4159-ab43-2eb67a93559b	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	3c8ea6da-5771-4096-a915-700e51ced05c	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	9c38abbc-2b3d-48d6-b629-4a163c803db5	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	efe06a26-30c5-437d-9fd1-4bd0062f1200	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	326c643a-23c5-4dab-9266-abc22ca1f874	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	5d738807-7f88-4943-9c3b-01f1e52ea72d	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Ascend Laboratories, LLC	e48db3c2-7351-41f2-a451-5a8341c4125c	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	9685792b-911d-4cf9-9881-d21abca48c66	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	c60752f8-20d5-4333-bf33-a656eab01d6b	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	0f72ec70-314c-4c9f-86be-54f3e010356d	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	REMEDYREPACK INC.	91edbe87-cd22-43a5-9952-1cd523b13820	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN