Application 065177

Type: ANDA
Sponsor: NEXUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	INJECTABLE;INJECTION	EQ 150MG BASE/VIAL	No	No

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
A065177-001	COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION			2004-03-19

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		2004-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		2004-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		2004-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065177-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-03-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065177-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065177-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065177-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065177-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065177-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065177-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065177-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065177-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065177-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065177-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065177-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065177-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065177-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065177-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065177-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065177-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065177-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065177-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065177-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065177-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065177-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065177-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065177-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065177-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065177-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065177-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065177-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065177-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065177-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065177-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065177-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065177-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065177-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065177-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065177-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065177-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065177-001	AP	1	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colistimethate	COLISTIMETHATE SODIUM	Xellia Pharmaceuticals USA LLC	8ec7dc90-825c-422e-9f4b-c8ace9d93af5	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: COLISTIMETHATE SODIUM
Colistimethate	COLISTIMETHATE SODIUM	Hikma Pharmaceuticals USA Inc.	bf556f89-6373-45cb-b465-d991fde7eab9	2026-03-06	Warnings, Adverse reactions	Name fallback generic name: COLISTIMETHATE SODIUM
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	6a335659-03b0-4a2d-9cd4-7dcf7da96fe6	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: COLISTIMETHATE SODIUM generic name: COLISTIMETHATE SODIUM
Colistimethate	COLISTIMETHATE SODIUM	Xellia Pharmaceuticals USA LLC	13dc3525-1879-4bd8-a922-81bc1397d5af	2024-08-29	Warnings, Adverse reactions	Name fallback generic name: COLISTIMETHATE SODIUM
Colistimethate	COLISTIMETHATE SODIUM	Fresenius Kabi USA, LLC	ab241809-0d2f-44ba-829c-26be67ee623f	2020-01-23	Warnings, Adverse reactions	Name fallback generic name: COLISTIMETHATE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
14789-201	Colistimethate Sodium	Colistimethate Sodium	Nexus Pharmaceuticals Inc	ANDA	Current
14789-201	Colistimethate Sodium	Colistimethate Sodium	Nexus Pharmaceuticals Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44217	ORIG	2007-06-29