Application 063206

Type: ANDA
Sponsor: XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPHOTERICIN B	AMPHOTERICIN B	INJECTABLE;INJECTION	50MG/VIAL	No	Yes

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
A063206-001	AMPHOTERICIN B	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION		RS	1992-04-29

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063206-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE / INJECTION	RS	1992-04-29	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amphotericin B	AMPHOTERICIN B	XGen Pharmaceuticals DJB, Inc.	a0a54943-9ce4-4f3e-b681-a1a9144c16ce	2022-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063206 application number: ANDA063206 ndc (product): 39822-1055

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
39822-1055	Amphotericin B	Amphotericin B	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-1055	Amphotericin B	Amphotericin B	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-1055	Amphotericin B	Amphotericin B	XGen Pharmaceuticals DJB, Inc.	ANDA	Current