FDA.reportPublic FDA data

Application 219859

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL25MGNoNo
002LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL50MGNoNo
003LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL100MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219859-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2025-09-19
A219859-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2025-09-19
A219859-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2025-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219859-001AB
A219859-002AB
A219859-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219859-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2025-09-1984e616aacf4f…
2026-09-14 22:38:342026-08A219859-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2025-09-1984e616aacf4f…
2026-09-14 22:38:342026-08A219859-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2025-09-1984e616aacf4f…
2026-08-18 06:07:402026-07A219859-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2025-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07A219859-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2025-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07A219859-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2025-09-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219859-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2025-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219859-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2025-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219859-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2025-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219859-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2025-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219859-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2025-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219859-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2025-09-1931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219859-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2025-09-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219859-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2025-09-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219859-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2025-09-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219859-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219859-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A219859-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A219859-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219859-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219859-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219859-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219859-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219859-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219859-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219859-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219859-003AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219859-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219859-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219859-003AB1a50c72e98297…

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 7 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOSARTAN POTASSIUMLOSARTAN POTASSIUMXLCare Pharmaceuticals, Inc.20421665-0401-4f6e-9e1d-232c654efb0f2023-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LOSARTAN POTASSIUM
generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUMLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC8015c22c-d944-4a49-8721-70d0c1b985262022-10-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LOSARTAN POTASSIUM
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LP5b1f6677-9473-467f-9fb6-efadbd8828e82022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LPc0319153-3e35-4a84-aa63-935b1e0047d82022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LP1b3c03e8-da8e-4c25-a493-118e760a003b2022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LPaeb4ce44-ab34-4f0e-a674-de42d404d1042022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMProficient Rx LPe8075254-cdfd-44f3-a9c2-1ed913f846ea2022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 mgLOSARTAN POTASSIUMProficient Rx LPf260f7c5-a55b-4294-ae02-2586929e24c92021-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LP435c5544-491b-476a-b950-712b2c18e3342020-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUMLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC2f738295-53d6-4d4f-8864-9faf893dbdf22020-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LOSARTAN POTASSIUM
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLCbe2432ba-2118-418a-addf-56db9b6c39d22020-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losortan PotassiumLOSARTAN POTASSIUMProficient Rx LP364fe10e-11ca-4ee6-9f67-c85dec09aca52019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LP44050993-c20e-45d4-baeb-f77d912961682019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC35e3472a-457f-4f95-a78d-dbff2595171d2019-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC1f55aaa2-5848-47e0-bba0-6a70b2fa05dd2018-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC3bcbcb6c-ee8d-44b1-9c78-92712291e8912018-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC8081b9f8-0b52-46dd-93f2-6bc608b753392018-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.