Application 016092

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EDECRIN	ETHACRYNIC ACID	TABLET;ORAL	25MG	Yes	Yes
002	EDECRIN	ETHACRYNIC ACID	TABLET;ORAL	50MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016092-001	EDECRIN	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N016092-002	EDECRIN	ETHACRYNIC ACID	50MG	TABLET / ORAL		Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016092-001	AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016092-001	EDECRIN	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016092-002	EDECRIN	50MG	TABLET / ORAL		Approved before 1982	`bb7c543d1eb4…`

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	N016092-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016092-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016092-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016092-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016092-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016092-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016092-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016092-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016092-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016092-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016092-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016092-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016092-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016092-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016092-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016092-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016092-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016092-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016092-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016092-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016092-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016092-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016092-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016092-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016092-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016092-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016092-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016092-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016092-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016092-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016092-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016092-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016092-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016092-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016092-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016092-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016092-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016092-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016092-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016092-001	AB	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
ethacrynic acid	ETHACRYNIC ACID	Oceanside Pharmaceuticals	f127598f-e6b3-4c35-800f-76e4217595ae	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016092 application number: NDA016092 ndc (product): 68682-011
EDECRIN	ETHACRYNIC ACID	Bausch Health US, LLC	1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8	2020-08-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016092 application number: NDA016092 ndc (product): 25010-215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25010-215	EDECRIN	ethacrynic acid	Aton Pharma, Inc.	NDA	Current
25010-215	EDECRIN	ethacrynic acid	Bausch Health US, LLC	NDA	Current
25010-215	EDECRIN	ethacrynic acid	Bausch Health US, LLC	NDA	Current
25010-215	EDECRIN	ethacrynic acid	Bausch Health US, LLC	NDA	Current
68682-011	ethacrynic acid	ethacrynic acid	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-011	ethacrynic acid	ethacrynic acid	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-011	ethacrynic acid	ethacrynic acid	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
69189-0371	EDECRIN	ethacrynic acid	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10870	SUPPL	2005-02-11
416	SUPPL	2005-02-11
12972	SUPPL	2004-03-02
40703	SUPPL	1999-10-19