Application 078943

Type: ANDA
Sponsor: PLIVA LACHEMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXALIPLATIN	OXALIPLATIN	INJECTABLE; INJECTION	5MG/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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	Baxter Healthcare Corporation	21a2bb1d-d91d-4f99-97dd-cc67fe99a090	2023-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Sandoz Inc	ab162009-6f84-4d56-ab56-5e84409ec814	2023-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Qilu Pharmaceutical Co., Ltd.	e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64	2021-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Gland Pharma Limited	d6178bc6-9dae-413f-8f47-de75d576c5b8	2017-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN

Reported adverse events (FAERS/openFDA)#

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