FDA.reportPublic FDA data

Application 216808

Type
ANDA
Sponsor
E5 PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IVERMECTINIVERMECTINTABLET;ORAL3MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216808-001IVERMECTINIVERMECTIN3MGTABLET / ORALAB2026-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216808-001AB

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 22:38:342026-08A216808-001IVERMECTIN3MGTABLET / ORALAB2026-03-0984e616aacf4f…
2026-08-18 06:07:402026-07A216808-001IVERMECTIN3MGTABLET / ORALAB2026-03-09caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216808-001IVERMECTIN3MGTABLET / ORALAB2026-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216808-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A216808-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216808-001AB1a50c72e98297…

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOOLANTRAIVERMECTINGalderma Laboratories, L.P.b1d5b166-ab06-4ab5-b0c6-31126238118a2024-10-24Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINBelmora LLC0d405318-3db5-41b6-a248-a6c1cfe7a7652024-10-17WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
STROMECTOLIVERMECTINMerck Sharp & Dohme LLC681888c9-af79-4b7d-ae80-c3f4f6f1effd2024-09-20Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
ivermectinIVERMECTINEPIC PHARMA LLCc8005642-3bf0-41b9-8a53-8b933c68c0732024-08-28Warnings, Adverse reactionsName fallback
brand name: ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINRite Aid Corporation3a2eb7f3-b72b-435c-a609-ce7050cccff42024-08-12WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINNuCare Pharmaceuticals,Inc.ad6539f2-94de-1bc5-e053-2a95a90a4cf22024-07-17Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
SkliceIVERMECTINAzurity Pharmaceuticals7579bdfe-a538-4bff-b7c7-df2c4b6f13db2024-07-11WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINBryant Ranch Prepack75973e89-a03f-48dd-8fe8-8eafc1938d092024-04-30Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINPadagis Israel Pharmaceuticals Ltd1d3e7aea-02a4-46b1-8a14-0324e4777cb42024-03-31Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
ivermectinIVERMECTINViona Pharmaceuticals Inc6b4a7400-d34c-4947-90e6-340f7087a7022024-03-27Adverse reactionsName fallback
brand name: ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINBryant Ranch Prepack81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc2023-10-30Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINAsclemed USA, Inc.014e33e7-c07d-4feb-a2cf-7cd160b1facd2023-10-05Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IVERMECTINIVERMECTINMayne Pharma Inc.39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd2023-08-29Adverse reactionsName fallback
brand name: IVERMECTIN
generic name: IVERMECTIN
ivermectinIVERMECTINZydus Lifesciences Limited22e85f9a-0805-47f2-8709-aa6514511b042023-06-07Name fallback
brand name: ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINWalgreen Companyb8e1d919-ba66-4dc0-b0fc-cfb3a229dad92022-01-04WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN

Reported adverse events (FAERS/openFDA)#

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