Application 050740

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMBISOME	AMPHOTERICIN B	INJECTABLE, LIPOSOMAL;INJECTION	50MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N050740-001	AMBISOME	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050740-001	AB

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 · 42 observed 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
2026-08-18 06:07:40	2026-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050740-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050740-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050740-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050740-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050740-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050740-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050740-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050740-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050740-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050740-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050740-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050740-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050740-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050740-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050740-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050740-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050740-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050740-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050740-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050740-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050740-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050740-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050740-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050740-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050740-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050740-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050740-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050740-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050740-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050740-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050740-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050740-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050740-001	AB	1	`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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-3051	AmBisome	amphotericin B	Astellas Pharma US, Inc.	NDA	Current
0469-3051	AmBisome	amphotericin B	Astellas Pharma US, Inc.	NDA	Current
0469-3051	AmBisome	amphotericin B	Astellas Pharma US, Inc.	NDA	Current
0469-3051	AmBisome	amphotericin B	Astellas Pharma US, Inc.	NDA	Current
0469-3051	AmBisome	amphotericin B	Astellas Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80181	SUPPL	2024-11-07
80173	SUPPL	2024-11-05
69290	SUPPL	2021-11-10
66098	SUPPL	2021-02-05
66097	SUPPL	2021-02-05
62949	SUPPL	2020-05-13
62942	SUPPL	2020-05-13
8152	SUPPL	2012-03-13
18151	SUPPL	2012-03-09
22212	ORIG	2009-06-19
39221	SUPPL	2008-11-07
30417	SUPPL	2008-10-14
42711	SUPPL	2004-05-27
18150	SUPPL	2003-09-26
30416	SUPPL	2003-09-25
42710	SUPPL	2003-07-31
18149	SUPPL	2000-07-18
8151	SUPPL	2000-07-18
18148	SUPPL	2000-01-28
8150	SUPPL	2000-01-28