Application 208686

Type: NDA
Sponsor: SILVERGATE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPANED	ENALAPRIL MALEATE	SOLUTION;ORAL	1MG/ML	Yes	Yes

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
N208686-001	EPANED	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208686-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208686-001	10039745	2036-03-25		Drug product	2018-08-23
N208686-001	10154987	2036-03-25	U-1723		2019-01-04
N208686-001	10154987	2036-03-25	U-185		2019-01-04
N208686-001	10154987	2036-03-25	U-1892		2019-01-04
N208686-001	10154987	2036-03-25	U-3		2019-01-04
N208686-001	10154987	2036-03-25	U-71		2019-01-04
N208686-001	10772868	2036-03-25		Drug product	2020-09-23
N208686-001	10786482	2036-03-25		Drug product	2020-10-08
N208686-001	11040023	2036-03-25		Drug product	2021-06-25
N208686-001	11141405	2036-03-25		Drug product	2021-10-19
N208686-001	11173141	2036-03-25		Drug product	2022-02-08
N208686-001	9669008	2036-03-25		Drug product	2017-06-09
N208686-001	9808442	2036-03-25	U-1723		2017-11-20
N208686-001	9808442	2036-03-25	U-185		2017-11-20
N208686-001	9808442	2036-03-25	U-1892		2017-11-20
N208686-001	9808442	2036-03-25	U-3		2017-11-20
N208686-001	9808442	2036-03-25	U-71		2017-11-20

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208686-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208686-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208686-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208686-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208686-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208686-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208686-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208686-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208686-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208686-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208686-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208686-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208686-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208686-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208686-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208686-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208686-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208686-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208686-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208686-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208686-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208686-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208686-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208686-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208686-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208686-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208686-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208686-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208686-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208686-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208686-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208686-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208686-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 680 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208686-001	10039745	2036-03-25		Drug product	2018-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-3		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-1892		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-185		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-71		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-1723		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10772868	2036-03-25		Drug product	2020-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10786482	2036-03-25		Drug product	2020-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	11040023	2036-03-25		Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	11141405	2036-03-25		Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	11173141	2036-03-25		Drug product	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9669008	2036-03-25		Drug product	2017-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-71		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-1723		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-185		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-1892		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-3		2017-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10039745	2036-03-25		Drug product	2018-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-3		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-1892		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-185		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-71		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-1723		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10772868	2036-03-25		Drug product	2020-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10786482	2036-03-25		Drug product	2020-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	11040023	2036-03-25		Drug product	2021-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	11141405	2036-03-25		Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	11173141	2036-03-25		Drug product	2022-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	9669008	2036-03-25		Drug product	2017-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	9808442	2036-03-25	U-71		2017-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	9808442	2036-03-25	U-1723		2017-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	9808442	2036-03-25	U-185		2017-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	9808442	2036-03-25	U-1892		2017-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	9808442	2036-03-25	U-3		2017-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	10039745	2036-03-25		Drug product	2018-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	10154987	2036-03-25	U-3		2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	10154987	2036-03-25	U-1892		2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	10154987	2036-03-25	U-185		2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	10154987	2036-03-25	U-71		2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	10154987	2036-03-25	U-1723		2019-01-04	`31067a03dcf5…`

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
Enalapril maleate	ENALAPRIL MALEATE	Wilshire Pharmaceuticals, Inc.	c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208686 application number: NDA208686
Epaned	ENALAPRIL MALEATE	Azurity Pharmaceuticals, Inc.	e6dbda02-779e-420c-893d-d0fea09432be	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208686 application number: NDA208686 ndc (product): 52652-4001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52652-4001	Epaned	enalapril maleate	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-4001	Epaned	enalapril maleate	Silvergate Pharmaceuticals, Inc.	NDA	Current
52652-4001	Epaned	enalapril maleate	Silvergate Pharmaceuticals, Inc.	NDA	Current
52652-4001	Epaned	enalapril maleate	Azurity Pharmaceuticals, Inc.	NDA	Current
69238-2141	Enalapril Maleate	Enalapril	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49151	SUPPL	2017-07-31
46971	ORIG	2017-01-24
46007	ORIG	2016-12-02
45496	ORIG	2016-09-22