Application 021723

Type: NDA
Sponsor: CP PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LYRICA	PREGABALIN	CAPSULE; ORAL	25MG	No	No
002	LYRICA	PREGABALIN	CAPSULE; ORAL	50MG	No	No
003	LYRICA	PREGABALIN	CAPSULE; ORAL	75MG	No	No
004	LYRICA	PREGABALIN	CAPSULE; ORAL	100MG	No	No
005	LYRICA	PREGABALIN	CAPSULE; ORAL	150MG	No	No
006	LYRICA	PREGABALIN	CAPSULE; ORAL	200MG	No	No
007	LYRICA	PREGABALIN	CAPSULE; ORAL	225MG	No	No
008	LYRICA	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 12 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	d58c0808-2ff9-4ce6-9c07-56f723592385	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
Pregabalin	PREGABALIN	Proficient Rx LP	a0f2b8af-0a04-4db0-adb3-d9d9369223d9	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
PREGABALIN	PREGABALIN	Asclemed USA, Inc.	69b8a843-a3a8-4d76-8418-f48288625030	2020-06-25	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	60185c88-ecfd-46f9-adb9-b97c6b00a553	2020-06-15	Warnings, Adverse reactions	Name fallback brand name: Lyrica generic name: PREGABALIN
PREGABALIN	PREGABALIN	Proficient Rx LP	4624c58f-8f77-48fa-be0f-fca4010cc8ae	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN
PREGABALIN	PREGABALIN	Proficient Rx LP	6022939f-92a8-4cb4-9f04-f237a4d73f6f	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
21792	ORIG	2005-12-02
44610	ORIG	2005-11-30
28471	ORIG	2005-01-11