Application 065088

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;OPHTHALMIC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	No	No

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

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
A065088-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC			2004-02-06

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A065088-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2004-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065088-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2004-02-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065088-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2004-02-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065088-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		2004-02-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065088-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065088-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065088-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065088-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065088-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065088-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065088-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065088-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065088-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065088-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065088-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065088-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065088-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A065088-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065088-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065088-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065088-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065088-001	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 and Bacitracin Zinc	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC	Bausch & Lomb Incorporated	f3231f1c-665e-4efa-baa1-83bf296b2f8f	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-7194	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	Henry Schein Inc.	ANDA	Current
0404-7194	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	Henry Schein Inc.	ANDA	Current
0404-7194	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	Henry Schein Inc.	ANDA	Current
13985-607	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	MWI	ANDA	Current
13985-607	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	MWI	ANDA	Current
13985-607	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	MWI	ANDA	Current
17478-235	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	Akorn, Inc.	ANDA	Current
17478-235	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	Akorn	ANDA	Current
17478-235	Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30651	ORIG	2004-06-09