Application 060014

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERMAPENPENICILLIN G BENZATHINEINJECTABLE;INJECTION600,000 UNITS/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
N060014-001PERMAPENPENICILLIN G BENZATHINE600,000 UNITS/MLINJECTABLE / INJECTIONApproved 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 22:54:322026-06N060014-001PERMAPEN600,000 UNITS/MLINJECTABLE / INJECTIONApproved 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BICILLIN L-APENICILLIN G BENZATHINEPfizer Laboratories Div Pfizer Inc012d46f1-d0a0-4676-a879-cd320297ab162026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PENICILLIN G BENZATHINE
BICILLIN L-APENICILLIN G BENZATHINEA-S Medication Solutionsa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce2023-10-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PENICILLIN G BENZATHINE