Application 090304

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DACTINOMYCIN	DACTINOMYCIN	INJECTABLE;INJECTION	0.5MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090304-001	DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE / INJECTION			2010-03-16

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090304-001	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE / INJECTION	2010-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090304-001	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE / INJECTION	2010-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090304-001	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE / INJECTION	2010-03-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090304-001	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE / INJECTION	2010-03-16	`a50c72e98297…`

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DACTINOMYCIN	DACTINOMYCIN	Eugia US LLC	5da55538-2602-4704-a9da-603c9f7ff7dc	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: DACTINOMYCIN generic name: DACTINOMYCIN
dactinomycin	DACTINOMYCIN	XGen Pharmaceuticals DJB, Inc.	efe03d73-eb11-45ff-a3cb-09a540ed352f	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: dactinomycin generic name: DACTINOMYCIN
Dactinomycin	DACTINOMYCIN	Hisun Pharmaceuticals USA, Inc.	95d5c152-aa00-41e6-83e8-8df374a56447	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Dactinomycin generic name: DACTINOMYCIN
DACTINOMYCIN	DACTINOMYCIN	Eugia US LLC	aa047ee8-f2e8-4720-84b1-d1c4532d6c63	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: DACTINOMYCIN generic name: DACTINOMYCIN
Dactinomycin	DACTINOMYCIN	Meitheal Pharmaceuticals Inc.	2aaca42a-3b79-4151-a727-83253556a540	2020-11-13	Warnings, Adverse reactions	Name fallback brand name: Dactinomycin generic name: DACTINOMYCIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43236	ORIG	2012-06-22