Application 203022

Type: ANDA
Sponsor: APOTEX INC

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.

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 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	REMEDYREPACK INC.	ab06a36d-9a2d-4eae-8991-4eab5bc8311c	2026-09-11	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
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

Reported adverse events (FAERS/openFDA)#

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