Application 212408

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	SOLUTION;ORAL	1MG/ML	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
A212408-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB		2021-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212408-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212408-001	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	2021-08-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212408-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212408-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212408-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212408-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212408-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212408-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212408-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212408-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212408-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212408-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212408-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212408-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212408-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212408-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212408-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212408-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212408-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212408-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212408-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212408-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212408-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212408-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212408-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212408-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212408-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212408-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212408-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212408-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212408-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212408-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212408-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212408-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212408-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212408-001	PC	2022-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212408-001	PC	2022-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212408-001	PC	2022-02-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212408-001	PC	2022-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212408-001	PC	2022-02-13	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A212408-001	PC	2022-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212408-001	PC	2022-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212408-001	PC	2022-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212408-001	PC	2022-02-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212408-001	PC	2022-02-13	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril maleate oral solution	ENALAPRIL MALEATE	Bionpharma Inc.	9391b8d8-2217-4838-8976-1a5ad90ef4ca	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212408 application number: ANDA212408 ndc (product): 69452-237

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
69452-237	Enalapril maleate oral solution	Enalapril maleate	Bionpharma Inc.	ANDA	Current
69452-237	Enalapril maleate oral solution	Enalapril maleate	Bionpharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65859	ORIG	2021-01-07