Application 065006

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE	SOLUTION/DROPS;OPHTHALMIC	10,000 UNITS/ML;EQ 1MG BASE/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
A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065006-001	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	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`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	A065006-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065006-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065006-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065006-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065006-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065006-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065006-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065006-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065006-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065006-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065006-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065006-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065006-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065006-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065006-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065006-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065006-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065006-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065006-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065006-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065006-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065006-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065006-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065006-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065006-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065006-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065006-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065006-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065006-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065006-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065006-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065006-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065006-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065006-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065006-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065006-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065006-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065006-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065006-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065006-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimethoprim sulfate and Polymyxin B sulfate	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	Proficient Rx LP	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065006 application number: ANDA065006 ndc (product): 63187-193

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-703	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Akorn, Inc.	ANDA	Current
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM	polymyxin b sulfate and trimethoprim	Akorn	ANDA	Current
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM	polymyxin b sulfate and trimethoprim	Akorn	ANDA	Current
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM	polymyxin b sulfate and trimethoprim	Akorn, Inc.	ANDA	Current
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM	polymyxin b sulfate and trimethoprim	Akorn	ANDA	Current
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM	polymyxin b sulfate and trimethoprim	Akorn, Inc.	ANDA	Current
55700-414	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-193	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Proficient Rx LP	ANDA	Current
63187-193	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Proficient Rx LP	ANDA	Current
68788-0536	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-0536	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-0536	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	Preferred Pharmaceuticals	ANDA	Current
70518-1194	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	REMEDYREPACK INC.	ANDA	Current
70518-1194	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate	REMEDYREPACK INC.	ANDA	Current
72189-005	POLYMYXIN B SULFATE AND TRIMETHOPRIM	POLYMYXIN B SULFATE AND TRIMETHOPRIM	Direct_Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30623	ORIG	1998-12-17