Application 065216

Type: ANDA
Sponsor: AMRING PHARMS

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
A065216-001	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			2005-10-31

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065216-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	2005-10-31	`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 2 of 2 · 22 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, HYDROCORTISONE	Proficient Rx LP	d55f1783-9c49-4f90-9ff8-6f132e7b325e	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Hydrocortisone
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Asclemed USA, Inc.	7c78ec84-8b7c-42f1-a879-3bf27a1daa71	2020-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Neomycin and Polymyxin B Sulfates and Hydrocortisone

Reported adverse events (FAERS/openFDA)#

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