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 2 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINRedPharm Drug, Incf4c298d5-b012-7b56-e053-2a95a90a3d552026-01-24Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINATLANTIC BIOLOGICALS CORP.5c08148f-83e5-4f14-b0d3-af8d2c26062e2026-01-13Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINChartwell RX, LLC30175930-f5fa-403d-a3ac-3bdbbe7236412025-12-17Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINKesin Pharma Corporation43817169-bbe8-58ee-e063-6294a90a12502025-12-11Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINChartwell Governmental & Specialty RX, LLC88a0a22e-8d6b-42aa-b225-2d57fb5b3a972025-11-12Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATIN CREAMNuCare Pharmaceuticals, Inc.42f21220-c68a-d748-e063-6394a90a1e2f2025-11-06Adverse reactionsName fallback
brand name: Nystatin
NystatinNYSTATINBryant Ranch Prepackb71356cf-7b6e-4ca0-9571-c80fd0d846cb2025-10-23Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINCardinal Health 107, LLC56aca0e2-8691-4701-beba-e2315524709f2025-10-23Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystopNYSTATINBryant Ranch Prepack64041bdf-1207-47f6-93f3-bc4656a7d2ae2025-10-21Adverse reactionsName fallback
generic name: NYSTATIN
NystopNYSTATINBryant Ranch Prepackaffea013-4f09-4e7d-a696-9f501d379af62025-10-21Adverse reactionsName fallback
generic name: NYSTATIN
NystatinNYSTATINBryant Ranch Prepackb6aa24e6-1acb-4fd3-9ec7-11b1a69c15982025-10-08Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINNorthstar Rx LLC9e6d0b0d-a68f-46aa-a707-3110ecb931b42025-09-30Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINBryant Ranch Prepack840eebe8-5de2-40c5-acfd-03a98b2e790e2025-09-23Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINAvKARE8fd35f97-5405-2160-ca0f-35034ecd5a922025-09-18Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINKanchan Healthcare Inc90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a2025-09-12Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystopNYSTATINBryant Ranch Prepack69ebb4dd-f45d-448d-97cd-3f89354939752025-08-26Adverse reactionsName fallback
generic name: NYSTATIN
nystatinNYSTATINBryant Ranch Prepacka5711dbe-f71c-435c-91f2-38c357532d182025-08-19Adverse reactionsName fallback
brand name: nystatin
generic name: NYSTATIN
NyamycNYSTATINUpsher-Smith Laboratories, LLC01b44f91-9b68-464a-9693-b5d3e793bf3c2025-07-09Adverse reactionsName fallback
generic name: NYSTATIN
NystatinNYSTATINSun Pharmaceutical Industries, Inc.4d845b3f-ca26-4c47-b424-b6d783cc10e52025-07-03Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
nystatinNYSTATINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.e87b8480-987d-4f82-87bf-cf831d6984a12025-06-23Adverse reactionsName fallback
brand name: nystatin
generic name: NYSTATIN

Reported adverse events (FAERS/openFDA)#

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