FDA.reportPublic FDA data

Application 062225

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATINNYSTATINCREAM;TOPICAL100,000 UNITS/GMNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062225-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A062225-001AT

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
2026-08-01 22:54:322026-06A062225-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062225-001AT1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MycostatinNYSTATINDirect_Rxf1857ac0-806c-4a7e-e053-2995a90abbc02026-03-17Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 72189-408
NystatinNYSTATINA-S Medication Solutionsf1b13a36-c349-4e26-a322-3ec02c6101552026-03-16Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 50090-2854
NystatinNYSTATINBryant Ranch Prepackb71356cf-7b6e-4ca0-9571-c80fd0d846cb2025-10-23Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINBryant Ranch Prepack840eebe8-5de2-40c5-acfd-03a98b2e790e2025-09-23Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 63629-8694
NystatinNYSTATINBryant Ranch Prepackcc8f9a06-cd1b-40e9-bc22-7e19f6d89b832025-04-02Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINNuCare Pharmaceuticals,Inc.6599b544-60bd-ab30-e053-2a91aa0a67b62024-11-20Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 68071-4293
NystatinNYSTATINA-S Medication Solutionsf410ba07-9183-40a8-a2a6-46d3e97614702024-11-06Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 50090-2763
NystatinNYSTATINBryant Ranch Prepackb69d9035-bdf5-4c5a-94d8-f8438f6f05672024-08-27Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 63629-8695
NystatinNYSTATINNuCare Pharmaceuticals,Inc.86cfb84c-dcd3-b229-e053-2a91aa0aed5c2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 66267-953
NystatinNYSTATINPadagis Israel Pharmaceuticals Ltde630aa3d-11a6-4300-942a-cbdf2d016f772024-03-01Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 45802-059
NystatinNYSTATINProficient Rx LPe7f0e152-233a-492e-a297-7bf2c543c1132022-05-02Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 63187-847

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-059NystatinNystatinPerrigo New York IncANDACurrent
45802-059NystatinNystatinPadagis Israel Pharmaceuticals LtdANDACurrent
50090-2763NystatinNystatinA-S Medication SolutionsANDACurrent
50090-2763NystatinNystatinA-S Medication SolutionsANDACurrent
50090-2854NystatinNystatinA-S Medication SolutionsANDACurrent
50090-2854NystatinNystatinA-S Medication SolutionsANDACurrent
63187-847NystatinNystatinProficient Rx LPANDACurrent
63187-847NystatinNystatinProficient Rx LPANDACurrent
63187-847NystatinNystatinProficient Rx LPANDACurrent
63187-847NystatinNystatinProficient Rx LPANDACurrent
63629-8694NystatinNystatinBryant Ranch PrepackANDACurrent
63629-8694NystatinNystatinBryant Ranch PrepackANDACurrent
63629-8694NystatinNystatinBryant Ranch PrepackANDACurrent
63629-8695NystatinNystatinBryant Ranch PrepackANDACurrent
63629-8695NystatinNystatinBryant Ranch PrepackANDACurrent
63629-8695NystatinNystatinBryant Ranch PrepackANDACurrent
66267-953NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-953NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4293NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4293NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4293NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4293NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3284NystatinNystatinREMEDYREPACK INC.ANDACurrent
72189-408MycostatinNystatinDirect_RxANDACurrent