FDA.reportPublic FDA data

Application 075627

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIR SODIUMACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 50MG BASE/MLNoNo

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
A075627-001ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 50MG BASE/MLINJECTABLE / INJECTION2001-03-28

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 22:54:322026-06A075627-001ACYCLOVIR SODIUMEQ 50MG BASE/MLINJECTABLE / INJECTION2001-03-28a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acyclovir SodiumACYCLOVIR SODIUMProPharma Distribution23a7cf9e-f21b-06c2-e063-6394a90aa6232025-07-18Warnings, Adverse reactionsName fallback
brand name: Acyclovir Sodium
generic name: ACYCLOVIR SODIUM
Acyclovir SodiumACYCLOVIR SODIUMEugia US LLCae921e4e-b8ae-4a45-acc1-32e5e719812b2023-07-05Warnings, Adverse reactionsName fallback
brand name: Acyclovir Sodium
generic name: ACYCLOVIR SODIUM
Acyclovir SodiumACYCLOVIR SODIUMAuroMedics Pharma LLCd3ab226c-677d-4cb7-85cb-1c2e5012f40d2017-09-18Warnings, Adverse reactionsName fallback
brand name: Acyclovir Sodium
generic name: ACYCLOVIR SODIUM

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30965ORIG2001-03-28