Application 089816

Type: ANDA
Sponsor: QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISONIAZID	ISONIAZID	Injectable; Injection	100MG/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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoniazid	ISONIAZID	Teva Pharmaceuticals USA, Inc.	9499f1cf-2f46-4047-8b71-90aee7dee854	2021-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Aphena Pharma Solutions - Tennessee, LLC	cb6f5638-2d3a-4334-b272-6b4772d32d03	2020-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Proficient Rx LP	65e50989-d24c-4bb3-a041-d6aea2635ef1	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID

Reported adverse events (FAERS/openFDA)#

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