Application 071082

Type: ANDA
Sponsor: QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL LACTATE	Injectable; Injection	EQ 5MG BASE/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 5 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL LACTATE	Hikma Pharmaceuticals USA Inc.	ec7a3560-71c3-43f5-bc6c-d51eadfd2aa1	2022-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	Amici Pharmaceuticals, LLC	9a9e20dd-646a-4fe9-a345-1b5bda8e7775	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL	HALOPERIDOL LACTATE	HF Acquisition Co LLC, DBA HealthFirst	beb6d1cf-98db-d0a5-e053-2995a90ace90	2021-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL generic name: HALOPERIDOL LACTATE

Reported adverse events (FAERS/openFDA)#

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