Application 065187

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 GRAMICIDIN	GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SOLUTION/DROPS;OPHTHALMIC	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT		2005-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065187-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065187-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	2005-10-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065187-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065187-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065187-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065187-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065187-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065187-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065187-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065187-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065187-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065187-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065187-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065187-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065187-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065187-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065187-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065187-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065187-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065187-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065187-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065187-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065187-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065187-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065187-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065187-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065187-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065187-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065187-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065187-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065187-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065187-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065187-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065187-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065187-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065187-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065187-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065187-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065187-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065187-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065187-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065187-001	AT	1	`e64feba35796…`

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 GRAMICIDIN	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN	A-S Medication Solutions	9691178e-5323-40ce-a8b3-f79e88f02797	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN	Bausch & Lomb Incorporated	e6f8d2f6-adff-4ae1-982c-45562f0a8e28	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN