Application 213611

Type: ANDA
Sponsor: NOVUGEN PHARMA SDN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	TABLET;ORAL	24MG;26MG	No	No
002	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	TABLET;ORAL	49MG;51MG	No	No
003	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	TABLET;ORAL	97MG;103MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213611-001	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16
A213611-002	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16
A213611-003	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213611-001	AB
A213611-002	AB
A213611-003	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
2026-08-18 06:07:40	2026-07	A213611-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213611-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213611-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213611-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213611-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213611-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213611-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213611-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213611-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213611-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213611-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213611-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213611-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213611-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213611-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`a50c72e98297…`

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	A213611-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213611-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213611-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213611-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213611-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213611-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213611-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213611-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213611-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213611-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213611-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213611-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213611-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213611-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213611-003	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	American Health Packaging	d85015d5-f619-4a58-b6ab-5e39af3f79d8	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213611 application number: ANDA213611
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	Novugen Pharma (USA) LLC	747eeb5c-ac2f-474f-b6d2-0586d12653a6	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213611 application number: ANDA213611
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	Novugen Pharma (USA) LLC	ec37696b-eaac-4c74-9328-94857ce998e5	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213611 application number: ANDA213611