Application 050495

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIKIN	AMIKACIN SULFATE	INJECTABLE;INJECTION	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AMIKIN	AMIKACIN SULFATE	INJECTABLE;INJECTION	EQ 250MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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
N050495-001	AMIKIN	AMIKACIN SULFATE	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N050495-002	AMIKIN	AMIKACIN SULFATE	EQ 250MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050495-001	AMIKIN	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050495-002	AMIKIN	EQ 250MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050495-001	AMIKIN	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050495-002	AMIKIN	EQ 250MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050495-001	AMIKIN	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050495-002	AMIKIN	EQ 250MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050495-001	AMIKIN	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050495-002	AMIKIN	EQ 250MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, 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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amikacin sulfate	AMIKACIN SULFATE	Sagent Pharmaceuticals	f260ff2a-76a0-4672-9516-91c344b67890	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE
Amikacin Sulfate	AMIKACIN SULFATE	Mullan Pharmaceutical Inc.	840ba25a-d60c-4f0d-a084-71b0c68237df	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE
Amikacin Sulfate	AMIKACIN SULFATE	Qilu Pharmaceutical Co., Ltd.	20fa61ef-11e2-4d01-82ea-b5412cefaead	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE
Amikacin Sulfate	AMIKACIN SULFATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	a43188fa-f228-4acd-8a5d-9a3462034f4b	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE
Amikacin Sulfate	AMIKACIN SULFATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	7791d3e1-9287-4f75-b4f0-e5d35cacfd6e	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE
Amikacin Sulfate	AMIKACIN SULFATE	Hikma Pharmaceuticals USA Inc.	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	2024-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE
Amikacin Sulfate	AMIKACIN SULFATE	Fresenius Kabi USA, LLC	c0f57839-1c9b-49e5-8c7a-708e2d16495d	2023-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMIKACIN SULFATE

Reported adverse events (FAERS/openFDA)#

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