Application 075940

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DACARBAZINE	DACARBAZINE	INJECTABLE;INJECTION	200MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075940-001	DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION			2001-10-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075940-001	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION			2001-10-18	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dacarbazine	DACARBAZINE	Hikma Pharmaceuticals USA Inc.	0d81315c-7021-4091-b703-ad135390c936	2025-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dacarbazine generic name: DACARBAZINE
Dacarbazine	DACARBAZINE	Meitheal Pharmaceuticals Inc.	64037f45-6245-49f0-9ae8-18d75753ae1f	2024-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dacarbazine generic name: DACARBAZINE
Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	b6b97e41-5f15-498c-abfb-d8443ea4d216	2022-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dacarbazine generic name: DACARBAZINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61703-327	Dacarbazine	DACARBAZINE	Hospira, Inc.	ANDA	Current
61703-327	Dacarbazine	DACARBAZINE	Hospira, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8840	ORIG	2003-04-16