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 9 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	af739a0d-a3cd-754f-e053-2a95a90ad655	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d28168cd-9b7a-f8df-e053-2995a90ad97f	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b8172d6b-a646-e559-e053-2a95a90ac24d	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	bc1b143d-feaf-9498-e053-2995a90acf50	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b817083c-b535-2269-e053-2a95a90af5b9	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c6b456ca-9d07-7789-e053-2a95a90a20c5	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8bfc4f9-6208-4eaa-e053-2a95a90ada97	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8acdbcf-3076-63b2-e053-2a95a90aa3c4	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c89a3514-f637-e54f-e053-2a95a90a6881	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d2804923-a466-6dc6-e053-2a95a90a4182	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f5d9b625-783c-bd78-e053-2995a90a37d2	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f8ae62be-3a68-be6b-e053-6394a90ab627	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	29b91992-c853-a57d-e063-6394a90ab365	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Quality Care Products, LLC	59432752-c8d8-4396-95dd-0e04c55bc82b	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Quality Care Products, LLC	1e087436-0534-4de2-b310-a5cc0e46adbd	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
PREGABALIN	PREGABALIN	Quality Care Products, LLC	ff386af0-17d3-4f95-803b-b51cb79e5295	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d2813712-d7f6-6144-e053-2995a90a3c5d	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: PREGABALIN generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	4cda70e8-9ae1-4958-8c86-1bc633be982b	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	cf7f0fd0-bac2-4836-9363-79d32ad0cc10	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Pregabalin generic name: PREGABALIN
Pregabalin	PREGABALIN	Bryant Ranch Prepack	08ad87e3-e00c-46d1-98f8-df493cf1712e	2024-09-06	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.