Application 065108

Type: ANDA
Sponsor: XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN AND POLYMYXIN B SULFATE	NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SOLUTION;IRRIGATION	EQ 40MG BASE/ML;200,000 UNITS/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	NEOMYCIN SULFATE; POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION		RS	2006-01-31

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION		RS	2006-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065108-001	NEOMYCIN AND POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION / IRRIGATION	AT		2006-01-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065108-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065108-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065108-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065108-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065108-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065108-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065108-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065108-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065108-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065108-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065108-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065108-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065108-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065108-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065108-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065108-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065108-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065108-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065108-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065108-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065108-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065108-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065108-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065108-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065108-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065108-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065108-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065108-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065108-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065108-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065108-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065108-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065108-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065108-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065108-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065108-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065108-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065108-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065108-001	AT	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates	NEOMYCIN AND POLYMYXIN B SULFATES	XGen Pharmaceuticals DJB, Inc.	a2f47d77-efd3-4c84-a364-08fb6d9978eb	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065108 application number: ANDA065108 ndc (product): 39822-1220

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
39822-1220	Neomycin and Polymyxin B Sulfates	Neomycin and Polymyxin B Sulfates	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-1220	Neomycin and Polymyxin B Sulfates	Neomycin and Polymyxin B Sulfates	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-1220	Neomycin and Polymyxin B Sulfates	Neomycin and Polymyxin B Sulfates	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-1220	Neomycin and Polymyxin B Sulfates	Neomycin and Polymyxin B Sulfates	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-1220	Neomycin and Polymyxin B Sulfates	Neomycin and Polymyxin B Sulfates	XGen Pharmaceuticals DJB, Inc.	ANDA	Current