Application 210058

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMBRISENTAN	AMBRISENTAN	TABLET;ORAL	5MG	No	No
002	AMBRISENTAN	AMBRISENTAN	TABLET;ORAL	10MG	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
A210058-001	AMBRISENTAN	AMBRISENTAN	5MG	TABLET / ORAL	AB		2019-03-28
A210058-002	AMBRISENTAN	AMBRISENTAN	10MG	TABLET / ORAL	AB		2019-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210058-001	AB
A210058-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A210058-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210058-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210058-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210058-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210058-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210058-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210058-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210058-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210058-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210058-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210058-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210058-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210058-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210058-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210058-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210058-002	AB	1	`bb7c543d1eb4…`

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
Ambrisentan	AMBRISENTAN	Zydus Pharmaceuticals USA Inc.	37af3191-0ed3-4783-8747-065f1462f2d2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210058 application number: ANDA210058 ndc (product): 70710-1180 ndc (product): 70710-1179
Ambrisentan	AMBRISENTAN	Quallent Pharmaceuticals Health LLC	6fc6032f-94dc-4067-8b24-01990ec99db0	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210058 application number: ANDA210058
Ambrisentan	AMBRISENTAN	Zydus Lifesciences Limited	0e3e3320-27ac-404f-9f01-3d82696e768a	2024-11-25		Exact identifier application applno (ANDA): 210058 application number: ANDA210058 ndc (product): 70771-1364 ndc (product): 70771-1363

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1179	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1179	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1179	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1179	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1179	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1180	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1180	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1180	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1180	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1180	Ambrisentan	Ambrisentan	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1363	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1363	Ambrisentan	Ambrisentan	Zydus Lifesciences Limited	ANDA	Current
70771-1363	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1363	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1363	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1364	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1364	Ambrisentan	Ambrisentan	Zydus Lifesciences Limited	ANDA	Current
70771-1364	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1364	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current
70771-1364	Ambrisentan	Ambrisentan	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76416	ORIG	2023-11-06
58169	APPL	2019-04-01
58159	ORIG	2019-04-01