Application 209261

Type: ANDA
Sponsor: UNICHEM LABS 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 1.

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
A209261-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	2018-05-04
A209261-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	2018-05-04
A209261-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	2018-05-04
A209261-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	2018-05-04

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209261-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209261-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209261-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209261-004	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A209261-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209261-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209261-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209261-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209261-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209261-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209261-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209261-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209261-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209261-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209261-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209261-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209261-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209261-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209261-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209261-004	AB	1	`ea99ee380514…`

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	Unichem Pharmaceuticals (USA), Inc.	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	2021-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209261 application number: ANDA209261 ndc (product): 29300-233 ndc (product): 29300-234 ndc (product): 29300-235 ndc (product): 29300-232

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
29300-232	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-232	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-232	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-232	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-232	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-233	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-233	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-233	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-233	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-233	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-234	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-234	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-234	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-234	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-234	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-235	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-235	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-235	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-235	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-235	Valsartan	Valsartan	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current