Application 065219

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	SUSPENSION/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 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
A065219-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		2006-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065219-001	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 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	A065219-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	2006-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065219-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	2006-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065219-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	2006-05-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065219-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	2006-05-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065219-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065219-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065219-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065219-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065219-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065219-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065219-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065219-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065219-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065219-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065219-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065219-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065219-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065219-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065219-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065219-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065219-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065219-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065219-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065219-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065219-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065219-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065219-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065219-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065219-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065219-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065219-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065219-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065219-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065219-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065219-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065219-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065219-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065219-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065219-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065219-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065219-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065219-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065219-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065219-001	AT	1	`3a93d1ddd44b…`

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 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 AND HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae	2026-08-04	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 AND HYDROCORTISONE	Preferred Pharmaceuticals Inc.	e7c7d23c-25f0-41ea-a563-59f46882d9fc	2026-08-04	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	Sportpharm LLC	9117d5f7-9020-4e76-9bd0-a690b6dfebd3	2026-07-17	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 AND HYDROCORTISONE	A-S Medication Solutions	1185a82b-e731-456a-8fc1-d9f0fc1ab0bc	2026-02-24	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	A-S Medication Solutions	498f34db-89e8-49cc-8543-87da3f4344ec	2026-02-04	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	REMEDYREPACK INC.	04fe1b32-adfb-4c36-a986-d81b49497e0f	2026-01-12	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	Amneal Pharmaceuticals NY LLC	6fff6c70-ea1f-449c-be0c-b989de36bd67	2025-11-07	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	Bausch & Lomb Incoporated	986e5b75-39fc-480f-9026-191b2d15dea1	2025-10-13	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 AND HYDROCORTISONE	Amneal Pharmaceuticals NY LLC	bea0457d-40a7-4af9-ac77-b04235680176	2025-10-06	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 AND HYDROCORTISONE	Sandoz Inc	ff34da77-5e96-4ed1-8c28-ba0b2f35576a	2025-08-20	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 AND HYDROCORTISONE	Bausch & Lomb Incorporated	b0ee85dd-5fe1-46a3-9bff-606e489d20b1	2025-04-30	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 AND HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	6296e2ed-336b-b9af-e053-2991aa0aae0c	2024-11-26	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 AND HYDROCORTISONE	A-S Medication Solutions	84d32193-c2cc-4837-88d1-c7d7dc2c7042	2024-11-18	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	NuCare Pharmaceuticals,Inc.	5f9c25b1-67d0-11ae-e053-2a91aa0ad8f4	2024-06-06	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 AND HYDROCORTISONE	Bryant Ranch Prepack	7a8e4f05-60f3-4492-a204-f26a251d8f65	2024-01-15	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 AND HYDROCORTISONE	Proficient Rx LP	f5ef71ae-fca9-4a57-ae88-f2b2d195a179	2022-08-01	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 AND HYDROCORTISONE	Proficient Rx LP	98042cef-2839-49d6-a7bd-a1d29c74430b	2022-05-02	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 AND HYDROCORTISONE	Proficient Rx LP	601cab21-c211-4c34-be7b-f4fdd97a921a	2022-05-02	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 AND HYDROCORTISONE	Sandoz Inc	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	2021-08-31	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 AND HYDROCORTISONE	Sandoz Inc.	99d9030f-9118-412c-a377-d1df1c8fa723	2021-08-31	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.