Home Applications 064042 Application 064042
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NYSTATIN NYSTATIN SUSPENSION;ORAL 100,000 UNITS/ML No No
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A064042-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1994-02-28
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nystatin NYSTATIN A-S Medication Solutions 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 2026-07-24 Adverse reactions Name fallback Nystatin NYSTATIN PAI Holdings, LLC dba PAI Pharma 28b4e26e-206a-4e8a-abfe-774b780e91c3 2026-07-21 Adverse reactions Name fallback Nystatin NYSTATIN Bryant Ranch Prepack 2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc 2026-07-09 Adverse reactions Name fallback NYSTATIN NYSTATIN Kesin Pharma Corporation 50737729-a4a4-e747-e063-6394a90adcc5 2026-06-30 Adverse reactions Name fallback NYSTATIN NYSTATIN Bryant Ranch Prepack 4f6f59fb-ae7d-48e5-b23e-a1d92160974f 2026-05-11 Adverse reactions Name fallback Nystatin NYSTATIN Torrent Pharmaceuticals Limited 4949dea7-d2b9-4e0d-974a-39408fa174ba 2026-05-08 Adverse reactions Name fallback NYSTATIN NYSTATIN Genus Lifesciences Inc. b25cbae5-eaf5-4501-b013-02c778ca4a4e 2026-05-07 Adverse reactions Name fallback Nystatin NYSTATIN Torrent Pharmaceuticals Limited 559b5bd4-3564-4437-8d0a-fa3a972f8b83 2026-05-01 Adverse reactions Name fallback Nystatin NYSTATIN A-S Medication Solutions f1b13a36-c349-4e26-a322-3ec02c610155 2026-03-16 Adverse reactions Name fallback Nystatin NYSTATIN Chartwell RX, LLC 9954118e-abe6-4388-98c9-4473d39b2e28 2026-03-05 Adverse reactions Name fallback Nystatin NYSTATIN Cardinal Health 107, LLC d59098da-1395-49fb-9fd6-947bbbeed56f 2026-02-26 Adverse reactions Name fallback Nystatin NYSTATIN Major Pharmaceuticals 17b9e33d-da9c-467a-bbc4-9e257727f19a 2026-02-23 Adverse reactions Name fallback Nystatin NYSTATIN RedPharm Drug, Inc f4c298d5-b012-7b56-e053-2a95a90a3d55 2026-01-24 Adverse reactions Name fallback NYSTATIN NYSTATIN ATLANTIC BIOLOGICALS CORP. 5c08148f-83e5-4f14-b0d3-af8d2c26062e 2026-01-13 Adverse reactions Name fallback Nystatin NYSTATIN Chartwell RX, LLC 30175930-f5fa-403d-a3ac-3bdbbe723641 2025-12-17 Adverse reactions Name fallback NYSTATIN NYSTATIN Kesin Pharma Corporation 43817169-bbe8-58ee-e063-6294a90a1250 2025-12-11 Adverse reactions Name fallback Nystatin NYSTATIN Chartwell Governmental & Specialty RX, LLC 88a0a22e-8d6b-42aa-b225-2d57fb5b3a97 2025-11-12 Adverse reactions Name fallback Nystatin NYSTATIN CREAM NuCare Pharmaceuticals, Inc. 42f21220-c68a-d748-e063-6394a90a1e2f 2025-11-06 Adverse reactions Name fallback Nystatin NYSTATIN Bryant Ranch Prepack b71356cf-7b6e-4ca0-9571-c80fd0d846cb 2025-10-23 Adverse reactions Name fallback Nystatin NYSTATIN Cardinal Health 107, LLC 56aca0e2-8691-4701-beba-e2315524709f 2025-10-23 Adverse reactions Name fallback
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General . ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
NDC Listings For This Application# NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42254-322 Nystatin Nystatin Rebel Distributors Corp ANDA Current 50090-3257 Nystatin Nystatin A-S Medication Solutions ANDA Current 50383-587 Nystatin Nystatin Akorn ANDA Current 50383-587 Nystatin Nystatin Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-587 Nystatin Nystatin Hi-Tech Pharmacal Co., Inc. ANDA Current