Application 062721

Type: ANDA
Sponsor: ALCON PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SUSPENSION/DROPS;OPHTHALMIC	0.1%;EQ 3.5MG BASE/ML;10,000 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
A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC			1986-11-17

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062721-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	1986-11-17	`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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	c3b6004a-8cfc-d5f8-e053-2a95a90a3efb	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Preferred Pharmaceuticals Inc.	e42d4837-77c2-40c3-8705-20966a51a822	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Sandoz Inc.	cf1a6da8-ba79-4bff-a13b-6effb67f6c1c	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	f1a05d5f-74f2-17a1-e053-2995a90ab0e7	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	a7e55c43-4345-4710-e053-2995a90aeee7	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Sandoz Inc	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	54da7bef-c3b0-4353-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	A-S Medication Solutions	6791e6c3-514d-4b98-8887-ca2b894576b5	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	A-S Medication Solutions	0d273133-0ce9-4fe6-b873-7f85aac25486	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Bausch & Lomb Incorporated	4456d10b-9995-4430-b692-a8859ea36deb	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Proficient Rx LP	21c9b34c-af88-4c9e-9b6c-32d78d34ba7e	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE	Proficient Rx LP	bd9f3220-6d42-4863-aa2a-b17b138d095d	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Proficient Rx LP	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Dexamethasone

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-595	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin B sulfate and dexamethasone	Rebel Distributors Corp	ANDA	Current