FDA.reportPublic FDA data

Application 220367

Type
ANDA
Sponsor
STERANCO HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATINNYSTATINSUSPENSION;ORAL100,000 UNITS/MLNoNo

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

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
A220367-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORAL2026-02-05

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
2026-09-14 22:38:342026-08A220367-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORAL2026-02-0584e616aacf4f…
2026-08-18 06:07:402026-07A220367-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORAL2026-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220367-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2026-02-05011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220367-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2026-02-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A220367-001AA1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220367-001AA1a50c72e98297…

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 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINProficient Rx LPe7f0e152-233a-492e-a297-7bf2c543c1132022-05-02Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINPharmaceutical Associates, Inc.31e3da10-5a7b-4bc5-8a4f-3e786b64c13a2022-01-13Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINMacleods Pharmaceuticals Limitedd8ebb61a-a326-4f0d-a346-c3db045c3fb02021-08-25Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
nystatinNYSTATINProficient Rx LP04d795f3-aad7-4b79-8ebc-43c500afe39b2021-08-01Adverse reactionsName fallback
brand name: nystatin
generic name: NYSTATIN
NystatinNYSTATINMacleods Pharmaceuticals Limitedfe3db8b2-9de4-4f9e-b763-8536a1e4cea82021-01-29Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATIN OINTMENTProficient Rx LP711950c4-1889-4acd-ab76-9a16176ce1e42020-03-01Adverse reactionsName fallback
brand name: Nystatin
NystatinNYSTATINProficient Rx LP5ef15e1c-66dc-4858-8552-d83e42c3883e2019-11-01Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINLeading Pharma, LLC8900ba02-2c6a-4dd4-b82f-45620c06e2552019-09-19Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN

Reported adverse events (FAERS/openFDA)#

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