Application 062423

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SOLUTION/DROPS;OTIC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT		1983-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062423-001	AT

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 · 43 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
2026-09-14 22:38:34	2026-08	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062423-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	1983-08-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062423-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062423-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062423-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062423-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062423-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062423-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062423-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062423-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062423-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062423-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062423-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062423-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062423-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062423-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062423-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062423-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062423-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062423-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062423-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062423-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062423-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062423-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062423-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062423-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062423-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062423-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062423-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062423-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062423-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062423-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062423-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062423-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062423-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062423-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062423-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062423-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062423-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062423-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062423-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062423-001	AT	1	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc	ff34da77-5e96-4ed1-8c28-ba0b2f35576a	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062423 application number: ANDA062423 ndc (product): 61314-646
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	f5ef71ae-fca9-4a57-ae88-f2b2d195a179	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062423 application number: ANDA062423 ndc (product): 63187-568

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2426	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	A-S Medication Solutions	ANDA	Current
53002-9060	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9060	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-282	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-282	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61314-646	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Sandoz Inc	ANDA	Current
61314-646	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Sandoz Inc	ANDA	Current
63187-568	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Proficient Rx LP	ANDA	Current
63187-568	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Proficient Rx LP	ANDA	Current
63187-568	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Proficient Rx LP	ANDA	Current
63187-568	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	Proficient Rx LP	ANDA	Current
68071-2735	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current