Application 204308

Type: NDA
Sponsor: SILVERGATE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPANED KIT	ENALAPRIL MALEATE	FOR SOLUTION;ORAL	1MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N204308-001	EPANED KIT	ENALAPRIL MALEATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		RLD	2013-08-13

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204308-001	8568747	2032-11-06		Drug product	2013-10-31
N204308-001	8778366	2032-11-06	U-1723		2014-07-16
N204308-001	8778366	2032-11-06	U-185		2014-07-16
N204308-001	8778366	2032-11-06	U-1892		2014-07-16
N204308-001	8778366	2032-11-06	U-3		2014-07-16
N204308-001	8778366	2032-11-06	U-71		2014-07-16
N204308-001	9855214	2032-11-06		Drug product	2018-01-10
N204308-001	9968553	2032-11-06	U-1723		2018-06-01
N204308-001	9968553	2032-11-06	U-185		2018-06-01
N204308-001	9968553	2032-11-06	U-1892		2018-06-01
N204308-001	9968553	2032-11-06	U-3		2018-06-01
N204308-001	9968553	2032-11-06	U-71		2018-06-01

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204308-001	EPANED KIT	1MG/ML	FOR SOLUTION / ORAL	RLD	2013-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204308-001	EPANED KIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	2013-08-13	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204308-001	8568747	2032-11-06		Drug product	2013-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	8778366	2032-11-06	U-3		2014-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	8778366	2032-11-06	U-71		2014-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	8778366	2032-11-06	U-185		2014-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	8778366	2032-11-06	U-1723		2014-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	8778366	2032-11-06	U-1892		2014-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	9855214	2032-11-06		Drug product	2018-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	9968553	2032-11-06	U-71		2018-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	9968553	2032-11-06	U-3		2018-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	9968553	2032-11-06	U-1892		2018-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	9968553	2032-11-06	U-185		2018-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204308-001	9968553	2032-11-06	U-1723		2018-06-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204308-001	8568747	2032-11-06		Drug product	2013-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	8778366	2032-11-06	U-3		2014-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	8778366	2032-11-06	U-71		2014-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	8778366	2032-11-06	U-185		2014-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	8778366	2032-11-06	U-1723		2014-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	8778366	2032-11-06	U-1892		2014-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	9855214	2032-11-06		Drug product	2018-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	9968553	2032-11-06	U-71		2018-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	9968553	2032-11-06	U-3		2018-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	9968553	2032-11-06	U-1892		2018-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	9968553	2032-11-06	U-185		2018-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204308-001	9968553	2032-11-06	U-1723		2018-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204308-001	8568747	2032-11-06		Drug product	2013-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	8778366	2032-11-06	U-3		2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	8778366	2032-11-06	U-71		2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	8778366	2032-11-06	U-185		2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	8778366	2032-11-06	U-1723		2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	8778366	2032-11-06	U-1892		2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	9855214	2032-11-06		Drug product	2018-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	9968553	2032-11-06	U-71		2018-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	9968553	2032-11-06	U-3		2018-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	9968553	2032-11-06	U-1892		2018-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	9968553	2032-11-06	U-185		2018-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204308-001	9968553	2032-11-06	U-1723		2018-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204308-001	8568747	2032-11-06		Drug product	2013-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204308-001	8778366	2032-11-06	U-3		2014-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204308-001	8778366	2032-11-06	U-71		2014-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204308-001	8778366	2032-11-06	U-185		2014-07-16	`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 3 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ENALAPRIL MALEATE	ENALAPRIL MALEATE	A-S Medication Solutions	fd0a7ecc-d6a2-4e04-a14f-1ed4dacb7df3	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Rising Pharma Holdings, Inc.	71e9fff3-7283-437e-b107-72fc16f09989	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	ec6c8c65-b438-40e3-9eb3-665d939abbdb	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	4f56955c-fc61-49ad-b42f-ff9d3386af6a	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	fd013f06-3456-c178-e053-6294a90a6bd9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	0b3dbe11-ff75-cb98-e063-6294a90ad2e9	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Northstar RxLLC	e109e7b1-4650-4416-9d89-7c1185d5cf48	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Coupler LLC	2cc892e2-1d91-e52a-e063-6394a90a6649	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	fe2dfa84-0276-6603-e053-6394a90af8ee	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	dfc439f7-83f5-4b9e-bbf2-f3d002860be3	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Chartwell RX, LLC	b1df1832-dce4-443f-87fc-e4177d069035	2024-10-09	Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril maleate oral solution	ENALAPRIL MALEATE	Bionpharma Inc.	9391b8d8-2217-4838-8976-1a5ad90ef4ca	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril maleate oral solution	ENALAPRIL MALEATE	NorthStar RxLLC	19606da3-c6b0-40a5-9690-77fc37072b51	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2061543d-67e7-46b6-aa56-cafa11ae4b93	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Aurobindo Pharma Limited	337707cc-4ed9-4121-bfff-c5015e5eca9d	2024-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	0ad4bfb4-62db-4759-af60-88eb031d125a	2023-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	f3754f29-9b75-4e2c-9c28-b3479f5bf906	2023-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	7b80abb4-fa75-48a4-a2e9-b0e31205234c	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	A-S Medication Solutions	ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f	2023-04-27	Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52652-1001	EPANED	enalapril maleate	Silvergate Pharmaceuticals, Inc.	NDA	Current
52652-1001	EPANED	enalapril maleate	Silvergate Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49184	SUPPL	2017-08-02
49152	SUPPL	2017-07-31
47679	SUPPL	2017-03-24
47655	SUPPL	2017-03-23
40374	SUPPL	2016-02-02
10321	SUPPL	2016-01-29
19544	SUPPL	2014-09-09
19543	SUPPL	2014-09-09
32542	SUPPL	2014-09-08
10320	SUPPL	2014-09-08
24466	ORIG	2014-06-27
22951	ORIG	2014-06-27
40373	ORIG	2013-08-15
10319	ORIG	2013-08-15