Application 201677

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALSARTAN	VALSARTAN	TABLET;ORAL	40MG	No	No
002	VALSARTAN	VALSARTAN	TABLET;ORAL	80MG	No	No
003	VALSARTAN	VALSARTAN	TABLET;ORAL	160MG	No	No
004	VALSARTAN	VALSARTAN	TABLET;ORAL	320MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201677-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	2015-01-05
A201677-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	2015-01-05
A201677-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	2015-01-05
A201677-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	2015-01-05

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 5 · 172 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
2026-09-14 22:38:34	2026-08	A201677-001	VALSARTAN	40MG	TABLET / ORAL		2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201677-002	VALSARTAN	80MG	TABLET / ORAL		2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201677-003	VALSARTAN	160MG	TABLET / ORAL		2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201677-004	VALSARTAN	320MG	TABLET / ORAL		2015-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201677-001	VALSARTAN	40MG	TABLET / ORAL		2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201677-002	VALSARTAN	80MG	TABLET / ORAL		2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201677-003	VALSARTAN	160MG	TABLET / ORAL		2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201677-004	VALSARTAN	320MG	TABLET / ORAL		2015-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201677-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201677-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201677-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201677-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201677-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201677-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201677-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201677-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201677-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201677-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201677-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201677-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201677-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201677-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201677-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201677-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201677-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201677-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201677-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201677-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201677-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201677-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201677-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201677-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201677-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201677-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201677-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201677-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201677-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201677-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201677-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201677-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201677-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201677-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201677-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201677-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201677-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201677-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201677-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201677-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201677-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201677-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201677-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201677-004	AB	1	`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
Valsartan	VALSARTAN	Lupin Pharmaceuticals, Inc.	9eb9d98e-7057-4ca0-91ab-2030bc0120a6	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201677 application number: ANDA201677 ndc (product): 68180-276 ndc (product): 68180-277 ndc (product): 68180-278 ndc (product): 68180-279

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-276	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-276	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-276	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-276	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-277	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-277	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-277	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-277	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-278	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-278	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-278	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-278	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-279	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-279	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-279	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-279	Valsartan	Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current