Application 040607

Type: ANDA
Sponsor: SAPTALIS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETIC ACID	ACETIC ACID, GLACIAL	SOLUTION/DROPS;OTIC	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040607-001	ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040607-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040607-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040607-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040607-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040607-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040607-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040607-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040607-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040607-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040607-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040607-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040607-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040607-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040607-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040607-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040607-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040607-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040607-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040607-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040607-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040607-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040607-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040607-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040607-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040607-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040607-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040607-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040607-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040607-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040607-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040607-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040607-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040607-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040607-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040607-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040607-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040607-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040607-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040607-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040607-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040607-001	AT	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetic Acid	ACETIC ACID	A-S Medication Solutions	c1c28375-9b03-4590-9d39-ab28403da93d	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040607 application number: ANDA040607
Acetic Acid	ACETIC ACID	NuCare Pharmaceuticals,Inc.	f9b4d18b-25f3-604f-e053-6394a90a5531	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040607 application number: ANDA040607
Acetic Acid	ACETIC ACID	TruPharma, LLC	0c5ebd59-0e98-4ea1-b279-9202a19f6dbf	2024-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040607 application number: ANDA040607 ndc (product): 52817-816

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52817-816	Acetic Acid	Acetic Acid	TruPharma, LLC	ANDA	Current