Application 076068

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No
002	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076068-001	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP		2004-09-28
A076068-002	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2004-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076068-001	AP
A076068-002	AP

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	A076068-001	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP		2004-09-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076068-002	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2004-09-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076068-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076068-002	AP	1	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexrazoxane	DEXRAZOXANE	Hikma Pharmaceuticals USA Inc.	68089182-d4a2-4053-8d0d-fc97a901515d	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076068 application number: ANDA076068 ndc (product): 0143-9247 ndc (product): 0143-9248

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9247	Dexrazoxane	Dexrazoxane	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9247	Dexrazoxane	Dexrazoxane	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9248	Dexrazoxane	Dexrazoxane	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9248	Dexrazoxane	Dexrazoxane	West-Ward Pharmaceuticals Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31069	ORIG	2004-10-04