Home Applications 065203 Application 065203
Type ANDA
Sponsor MAYNE PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065203-001 NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065203-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A065203-001 AT 1 a50c72e98297…
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. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16714-769 Nystatin Nystatin NorthStar Rx LLC ANDA Current 16714-769 Nystatin Nystatin NorthStar Rx LLC ANDA Current 42254-303 Nystatin Nystatin Rebel Distributors Corp ANDA Current 68308-152 Nystatin Nystatin Mayne Pharma Inc. ANDA Current 68308-152 Nystatin Nystatin Mayne Pharma Inc. ANDA Current 68308-152 Nystatin Nystatin Mayne Pharma Inc. ANDA Current 68308-152 Nystatin Nystatin Mayne Pharma Inc. ANDA Current 76519-1007 Nystatin Nystatin H.J. Harkins Company, Inc. ANDA Current