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 3 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINAurobindo Pharma Limited7d8a30ab-465e-4804-a06b-afd689e166832025-06-18Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINA-S Medication Solutionsa1b5ccb2-d0d6-46cc-b792-6920b50d0a032025-05-15Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINBryant Ranch Prepack72dc2b60-29a4-48a8-848a-1a5086cfdd582025-04-03Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINBryant Ranch Prepackcc8f9a06-cd1b-40e9-bc22-7e19f6d89b832025-04-02Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINNuCare Pharmaceuticals,Inc.cf6b7c68-7769-1808-e053-2995a90aa4262025-02-10Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINPadagis Israel Pharmaceuticals Ltd6c091c66-2e4d-4412-b7bf-35315dc8152f2025-01-23Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINDIRECT RXcd387929-5b72-e3c0-e053-2a95a90adb222025-01-20Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NYSTATINNYSTATINNuCare Pharmaceuticals,Inc.0b4dfd5e-641e-40e9-e063-6294a90a3fda2025-01-03Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NYSTATINNYSTATINZydus Lifesciences Limited5d593aa9-f2e4-4adf-9f02-37832ffcb5b42024-12-03Name fallback
brand name: NYSTATIN
generic name: NYSTATIN
NYSTATINNYSTATINLeading Pharma, LLC954205d8-47ba-4c89-95cd-f0066a514cf92024-11-28Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINNuCare Pharmaceuticals,Inc.6599b544-60bd-ab30-e053-2a91aa0a67b62024-11-20Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINA-S Medication Solutionsf410ba07-9183-40a8-a2a6-46d3e97614702024-11-06Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystopNYSTATINPadagis US LLCe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f2024-10-31Adverse reactionsName fallback
generic name: NYSTATIN
NystatinNYSTATINA-S Medication Solutions65167baa-29f8-44d3-b2d2-935c862d463e2024-10-16Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINBryant Ranch Prepackb69d9035-bdf5-4c5a-94d8-f8438f6f05672024-08-27Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINZydus Lifesciences Limited6aa2f67e-9636-45e5-be1b-83e7ab86e4362024-08-16Name fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINNuCare Pharmaceuticals,Inc.57825c04-dcb5-b76d-e053-2991aa0a4c1d2024-08-14Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINNuCare Pharmaceuticals,Inc.86cfb84c-dcd3-b229-e053-2a91aa0aed5c2024-08-14Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINLeading Pharma, LLC089e6444-2bd1-443e-acf0-dfeaa69faef92024-04-18Name fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINDr. Reddy's Labratories Inc.6bde84a1-341d-09ce-58b6-f9a653dc98c52024-04-12Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN

Reported adverse events (FAERS/openFDA)#

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