FDA.reportPublic FDA data

Application 062755

Type
ANDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062755-001NALLPENNAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-19
A062755-002NALLPENNAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-19

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.

Product history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A062755-001NALLPENEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-19e64feba35796…
2022-09-29 23:25 UTC2022-09A062755-002NALLPENEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062755-001NALLPENEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-19cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062755-002NALLPENEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062755-001NALLPENEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062755-002NALLPENEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-19a50c72e98297…

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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NafcillinNAFCILLIN SODIUMHeritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.8a00624c-c436-4102-a042-dab54022bcc22026-07-28Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NAFCILLIN SODIUMNAFCILLIN SODIUMONESOURCE SPECIALTY PHARMA LIMITED4b3b8e52-df96-4886-e063-6294a90ac63f2026-03-09Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NAFCILLIN SODIUMNAFCILLIN SODIUMArmas Pharmaceuticals Inc.090fda61-b9c8-640e-e063-6294a90a73632025-09-30Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMEugia US LLC90717878-64cb-4ffc-90bc-7b4e81e3d1cd2025-08-16Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMEugia US LLC8ec288e6-4d7f-4fea-a5ab-f9f337ebaa862025-08-16Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMEugia US LLC34821770-929c-40ea-a9e4-d4405dc869e12025-08-12Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMEugia US LLC0f21384c-0f82-4d99-a05c-6773d1ee4bcf2025-08-12Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMAvenacy Inc.0556378a-b794-4235-ba09-ebdc295e90922025-02-01Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMNorthStar Rx, LLCae5fb012-4012-4063-b2e4-f1f927c6bf742024-07-09Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMFresenius Kabi USA, LLC3c2581a1-8051-4d7a-a1f7-521248648dc92019-05-24Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM
NafcillinNAFCILLIN SODIUMFresenius Kabi USA, LLCc39721a3-7b22-4720-9dbd-bc82f03d2af72019-05-17Warnings, Adverse reactionsName fallback
generic name: NAFCILLIN SODIUM

Reported adverse events (FAERS/openFDA)#

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