Application 064045

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIKACIN SULFATE	AMIKACIN SULFATE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No
002	AMIKACIN SULFATE	AMIKACIN SULFATE	INJECTABLE;INJECTION	EQ 250MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A064045-001	AMIKACIN SULFATE	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION			1993-09-28
A064045-002	AMIKACIN SULFATE	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP		1993-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064045-002	AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064045-001	AMIKACIN SULFATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		1993-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064045-002	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1993-09-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064045-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064045-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064045-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064045-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064045-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064045-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064045-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064045-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064045-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064045-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064045-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064045-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064045-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064045-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064045-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064045-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064045-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A064045-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064045-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064045-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064045-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064045-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064045-002	AP	1	`c0c555d07b60…`
2019-09-15 20:21 UTC	2019-09	A064045-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064045-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064045-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064045-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064045-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064045-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064045-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064045-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064045-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064045-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064045-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064045-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064045-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064045-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064045-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A064045-002	AP	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amikacin Sulfate	AMIKACIN SULFATE	Mullan Pharmaceutical Inc.	840ba25a-d60c-4f0d-a084-71b0c68237df	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amikacin Sulfate 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 brand name: Amikacin Sulfate 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 brand name: Amikacin Sulfate 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 brand name: Amikacin Sulfate 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 brand name: Amikacin Sulfate 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 brand name: Amikacin Sulfate generic name: AMIKACIN SULFATE
amikacin sulfate	AMIKACIN SULFATE	Sagent Pharmaceuticals	f260ff2a-76a0-4672-9516-91c344b67890	2022-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: amikacin sulfate generic name: AMIKACIN SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-9032	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9032	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9032	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9032	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9040	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9040	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9040	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-9040	Amikacin Sulfate	Amikacin Sulfate	Teva Parenteral Medicines, Inc.	ANDA	Current