Application 050313

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUNGIZONE	AMPHOTERICIN B	OINTMENT;TOPICAL	3%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050313-001	FUNGIZONE	AMPHOTERICIN B	3%	OINTMENT / TOPICAL		Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N050313-001	FUNGIZONE	3%	OINTMENT / TOPICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050313-001	FUNGIZONE	3%	OINTMENT / TOPICAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050313-001	FUNGIZONE	3%	OINTMENT / TOPICAL	Approved before 1982	`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
Amphotericin B	AMPHOTERICIN B	Sun Pharmaceutical Industries, Inc.	02aadef1-390b-4270-b56d-33452eb89dde	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: AMPHOTERICIN B
Amphotericin B	AMPHOTERICIN B	Sun Pharmaceutical Industries, Inc.	593cffa0-c305-48b6-8ec7-331e0ff91d2b	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: AMPHOTERICIN B
Amphotericin B	AMPHOTERICIN B	Eugia US LLC	6f24975c-5191-4fc2-a8da-e57358f8e154	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: AMPHOTERICIN B
Amphotericin B	AMPHOTERICIN B	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2b2f3ff5-9d62-4ad2-8eac-1181e5911513	2025-06-03	Warnings, Adverse reactions	Name fallback generic name: AMPHOTERICIN B
Amphotericin B	AMPHOTERICIN B	XGen Pharmaceuticals DJB, Inc.	a0a54943-9ce4-4f3e-b681-a1a9144c16ce	2022-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMPHOTERICIN B

Reported adverse events (FAERS/openFDA)#

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