FDA.reportPublic FDA data

Application 090642

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTANVALSARTANTABLET;ORAL40MGNoNo
002VALSARTANVALSARTANTABLET;ORAL80MGNoNo
003VALSARTANVALSARTANTABLET;ORAL160MGNoNo
004VALSARTANVALSARTANTABLET;ORAL320MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090642-001VALSARTANVALSARTAN40MGTABLET / ORAL2015-01-05
A090642-002VALSARTANVALSARTAN80MGTABLET / ORAL2015-01-05
A090642-003VALSARTANVALSARTAN160MGTABLET / ORAL2015-01-05
A090642-004VALSARTANVALSARTAN320MGTABLET / ORAL2015-01-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090642-001VALSARTAN40MGTABLET / ORAL2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A090642-002VALSARTAN80MGTABLET / ORAL2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A090642-003VALSARTAN160MGTABLET / ORAL2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A090642-004VALSARTAN320MGTABLET / ORAL2015-01-0584e616aacf4f…
2026-08-18 06:07:402026-07A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-001VALSARTAN40MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-002VALSARTAN80MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-003VALSARTAN160MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-004VALSARTAN320MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090642-001VALSARTAN40MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090642-002VALSARTAN80MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090642-003VALSARTAN160MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090642-004VALSARTAN320MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-001VALSARTAN40MGTABLET / ORAL2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-002VALSARTAN80MGTABLET / ORAL2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-003VALSARTAN160MGTABLET / ORAL2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-004VALSARTAN320MGTABLET / ORAL2015-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-001VALSARTAN40MGTABLET / ORAL2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-002VALSARTAN80MGTABLET / ORAL2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-003VALSARTAN160MGTABLET / ORAL2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-004VALSARTAN320MGTABLET / ORAL2015-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-001VALSARTAN40MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-002VALSARTAN80MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-003VALSARTAN160MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-004VALSARTAN320MGTABLET / ORAL2015-01-055bbf6a4d5a75…

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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANA-S Medication Solutionsd9af6ba1-c760-4af6-b733-88e4892d4cb62026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANAvKAREa8c61488-4219-dfcb-e053-2a95a90a98a42026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANNorthwind Health Company, LLCf2b77f2f-333e-f3e3-e053-2a95a90a1fa72026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANNorthwind Health Company, LLCf305e9d7-341a-45f6-e053-2a95a90a2d692026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANNorthwind Health Company, LLCf756009f-f04f-6518-e053-6294a90a79ed2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANNorthwind Health Company, LLC03af7d09-314a-fe85-e063-6294a90afa252026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
valsartanVALSARTANNorthwind Health Company, LLCdb4801e5-6e0f-2cb3-e053-2995a90a709a2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: valsartan
generic name: VALSARTAN
ValsartanVALSARTANAscend Laboratories, LLC7b4ecaf9-e84c-4660-9cd1-65a238efd8a82025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANCoupler LLC3eee9505-ebba-76e3-e063-6294a90acd6e2025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANCoupler LLC3dfe5407-96a6-d2f4-e063-6294a90aa8102025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANSolco Healthcare US, LLC26080940-bcd3-446d-9026-3ddfb58e281e2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANDr. Reddy's Laboratories Limited75235313-8a07-8849-9b5a-12887992033e2025-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTAN ORALAdvagen Pharma Ltd47137b1a-f2b0-49af-99f0-6fb4f5a165782025-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
valsartanVALSARTANPD-Rx Pharmaceuticals, Inc.5afd7c3d-c66b-479c-bfd0-6c04658b157d2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: valsartan
generic name: VALSARTAN
ValsartanVALSARTANProficient Rx LPf59f71d3-c143-43e5-ac22-0b1d741f4a812025-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
VALSARTANVALSARTANDirect_Rx946692f5-0fe2-89b7-e053-2995a90a4d912025-01-27Warnings, Adverse reactionsName fallback
brand name: VALSARTAN
generic name: VALSARTAN
ValsartanVALSARTANCamber Pharmaceuticals, Inc.0ff36e83-b307-42db-a2ab-bae3f6805c202025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANAvPAK0878f27e-5368-c93f-e063-6394a90a10862025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANA-S Medication Solutions2847db2a-fcc9-4776-875a-ba6d57d5ea8b2024-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN
ValsartanVALSARTANAmerican Health Packaging7ea2fdf1-4fda-47a7-8110-62fb6468c9892024-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Valsartan
generic name: VALSARTAN

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2167ValsartanvalsartanActavis Pharma, Inc.ANDACurrent
0591-2168ValsartanvalsartanActavis Pharma, Inc.ANDACurrent
0591-2169ValsartanvalsartanActavis Pharma, Inc.ANDACurrent
0591-2170ValsartanvalsartanActavis Pharma, Inc.ANDACurrent
0904-6594ValsartanvalsartanMajor PharmaceuticalsANDACurrent
0904-6595ValsartanvalsartanMajor PharmaceuticalsANDACurrent
50436-2168ValsartanValsartanUnit Dose ServicesANDACurrent
71335-0600ValsartanValsartanBryant Ranch PrepackANDACurrent