Application 040166

Type: ANDA
Sponsor: WOCKHARDT BIO AG

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	Yes

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
A040166-001	ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS / OTIC			1996-07-26

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	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040166-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040166-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040166-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040166-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040166-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040166-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040166-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040166-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040166-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040166-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040166-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040166-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040166-001	AT	1	`ea99ee380514…`

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
ACETIC ACID	ACETIC ACID	Chartwell RX, LLC	2aaf3781-4f25-4799-8dcd-78d67e226ccc	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040166 application number: ANDA040166

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3020	ACETIC ACID	Acetic Acid	A-S Medication Solutions	ANDA	Current
50436-4600	Acetic Acid	Acetic Acid	Unit Dose Services	ANDA	Current
60432-741	ACETIC ACID	Acetic Acid	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
68071-3304	Acetic Acid	ACETIC ACID	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22088	ORIG	2003-07-30