Application 202998

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	SOLUTION;ORAL	20MG/ML	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 11 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	38e80423-0194-4064-9447-abfd29fce1da	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	d2a98872-1a52-47e1-b4bd-0ff7d6272a92	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	27d02970-5f8b-4f4f-b89e-e42cc78ddaa3	2023-11-28	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	137ffe30-ff8b-409d-a719-6be19d4d9522	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a17f03ea-9375-48fe-be32-f8df509f5fba	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Alembic Pharmaceuticals Limited	78a36538-701d-4dd9-a7fc-87d505784c83	2023-05-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	1d76c6a3-7899-4dec-afcc-2b575dfa6c25	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	920c57e0-ddfe-4750-b353-5f96b65443cf	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Tris Pharma Inc	62aa850d-199c-44d5-a730-45f43efa850e	2022-11-30	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	df80e09f-3d57-47a0-ba58-bb79e9ba1953	2022-11-29	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Asclemed USA, Inc.	3d2464fb-b3ac-496e-b8a5-c2e8a902ce29	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin Extended Release	PREGABALIN	ScieGen Pharmaceuticals, INC.	1544a657-353c-47f8-96ac-a63fa78373f0	2022-09-19	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	65311ae9-e440-4650-b1b1-6f4495fda93c	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	c7986739-3fc9-4a1d-8dd6-2e11cf1f3610	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	68829d7b-ab40-429e-92dc-91f8a0d49afd	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Patrin Pharma, Inc.	d92c94e5-e542-4177-afa8-fa00ba17634c	2022-06-21	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a1545bbb-b337-4760-ab4c-fb76ab019337	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	1503dd3b-688b-4702-8fc1-954b5ffe4235	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	9b1472ac-8b79-4f22-ae50-3b0942bd62b1	2022-04-01	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.