Application 006823

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AQUASOL AVITAMIN A PALMITATEINJECTABLE;INJECTIONEQ 50,000 UNITS BASE/MLYesYes

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
N006823-001AQUASOL AVITAMIN A PALMITATEEQ 50,000 UNITS BASE/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982

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 22:54:322026-06N006823-001AQUASOL AEQ 50,000 UNITS BASE/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AQUASOL A ParenteralWATER-MISCIBLE RETINYL PALMITATERising Pharma Holdings, Inc.1abd66eb-6ac8-4a9e-a609-251e46ea1a272026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 006823
application number: NDA006823

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61703-418AQUASOL AVITAMIN A PALMITATEHospira, Inc.NDACurrent
61703-418AQUASOL AVITAMIN A PALMITATEHospira, Inc.NDACurrent
61703-418AQUASOL AVITAMIN A PALMITATEHospira, Inc.NDACurrent
61703-418AQUASOL AVITAMIN A PALMITATEHospira, Inc.NDACurrent
70199-026AQUASOL AVITAMIN A PALMITATECasper Pharma LLCNDACurrent