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 2 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMSt. Mary's Medical Park Pharmacyaaf943ff-d6af-8ce2-e053-2995a90a7b762026-06-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMCardinal Health 107, LLCb83d896a-c7e9-4508-814c-425b88a87b162026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack0f3a6984-e601-4a74-9910-49ee5e352d6b2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMCoupler LLC53456224-db79-e7c1-e063-6394a90a90d52026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.c4b81f90-bcd0-45d0-99ce-35ca998d473a2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losortan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.25651749-8950-43ff-bcbd-3bb85f57a3602026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals, Inc.fe1df76d-4925-444d-8e30-9dd07f205fb72026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.f9a92771-5c73-4f17-ac38-29fabfd4a9192026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.5f7612dc-dccf-49e2-b541-3dab9dc1f97a2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.abb56236-f2fe-45b5-93ac-35fd661f89922026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losortan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack1b285c10-f468-4d87-b36d-79047f686c582026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions23117ad8-39ad-44f2-b7d2-2dbc8edc97342026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutionsd7b61f05-871d-4ffd-ab9b-9a3e60fd34c42026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan potassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.05818573-0b40-4731-a9d1-152c708905bf2026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan potassium
generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.4d60e755-40a6-4187-b09e-e55c735945aa2026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ba76eb91-bea6-4e37-e053-2a95a90a065a2026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mgLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.372ba4ad-26ca-4675-8475-4b664fbecba92026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions3ee3240f-78a1-4fd2-a779-c226937117212026-02-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutionsf29cc61a-afba-4ecb-8043-5f103872f1ae2026-02-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Losartan Potassium
generic name: LOSARTAN POTASSIUM
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions2c810cde-fa40-4772-806e-c31809e6bbfb2026-02-11Boxed 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.