FDA.reportPublic FDA data

Application 204154

Type
ANDA
Sponsor
EDENBRIDGE PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204154-001IVERMECTINIVERMECTIN3MGTABLET / ORALAB2014-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204154-001AB

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
2026-08-01 22:54:322026-06A204154-001IVERMECTIN3MGTABLET / ORALAB2014-10-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204154-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINA-S Medication Solutions104a5045-94b1-4022-bc49-719521f30f0d2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154
ndc (product): 50090-5587
IvermectinIVERMECTINEdenbridge Pharmaceuticals LLC.847a1dd7-d65b-4a0e-a67d-d90392059dac2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154
ndc (product): 42799-806
IvermectinIVERMECTINNuCare Pharmaceuticals,Inc.ad6539f2-94de-1bc5-e053-2a95a90a4cf22024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154
ndc (product): 68071-2242
IvermectinIVERMECTINAsclemed USA, Inc.014e33e7-c07d-4feb-a2cf-7cd160b1facd2023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42799-806IvermectinIvermectinEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-806IvermectinIvermectinEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-806IvermectinIvermectinEdenbridge Pharmaceuticals, LLCANDACurrent
50090-5587IvermectinIvermectinA-S Medication SolutionsANDACurrent
63629-7275IvermectinIvermectinBryant Ranch PrepackANDACurrent
63629-7275IvermectinIvermectinBryant Ranch PrepackANDACurrent
68071-2242IvermectinIvermectinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2242IvermectinIvermectinNuCare Pharmaceuticals,Inc.ANDACurrent
76413-155IvermectinIvermectinCentral Texas Community Health CentersANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19532ORIG2014-10-30
32522ORIG2014-10-28