FDA.reportPublic FDA data

Application 062124

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NYSTATINNYSTATINOINTMENT;TOPICAL100,000 UNITS/GMNoYes

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
A062124-002NYSTATINNYSTATIN100,000 UNITS/GMOINTMENT / TOPICALATRS1982-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062124-002AT

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 22:54:322026-06A062124-002NYSTATIN100,000 UNITS/GMOINTMENT / TOPICALATRS1982-09-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062124-002AT1a50c72e98297…

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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINA-S Medication Solutions98bd8ccb-0c68-47b9-bcb4-c5d8217868d92026-07-24Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINPAI Holdings, LLC dba PAI Pharma28b4e26e-206a-4e8a-abfe-774b780e91c32026-07-21Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystopNYSTATINBryant Ranch Prepack0bb31239-fb77-442a-a9ee-ba61b45e7e682026-07-14Adverse reactionsName fallback
generic name: NYSTATIN
NystatinNYSTATINBryant Ranch Prepack2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc2026-07-09Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINKesin Pharma Corporation50737729-a4a4-e747-e063-6394a90adcc52026-06-30Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NYSTATINNYSTATINBryant Ranch Prepack4f6f59fb-ae7d-48e5-b23e-a1d92160974f2026-05-11Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINTorrent Pharmaceuticals Limited4949dea7-d2b9-4e0d-974a-39408fa174ba2026-05-08Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NYSTATINNYSTATINGenus Lifesciences Inc.b25cbae5-eaf5-4501-b013-02c778ca4a4e2026-05-07Adverse reactionsName fallback
brand name: NYSTATIN
generic name: NYSTATIN
NystatinNYSTATINTorrent Pharmaceuticals Limited559b5bd4-3564-4437-8d0a-fa3a972f8b832026-05-01Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
MycostatinNYSTATINDirect_Rxf1857ac0-806c-4a7e-e053-2995a90abbc02026-03-17Adverse reactionsName fallback
generic name: NYSTATIN
NystatinNYSTATINA-S Medication Solutionsf1b13a36-c349-4e26-a322-3ec02c6101552026-03-16Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINChartwell RX, LLC9954118e-abe6-4388-98c9-4473d39b2e282026-03-05Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINCardinal Health 107, LLCd59098da-1395-49fb-9fd6-947bbbeed56f2026-02-26Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
NystatinNYSTATINMajor Pharmaceuticals17b9e33d-da9c-467a-bbc4-9e257727f19a2026-02-23Adverse reactionsName fallback
brand name: Nystatin
generic name: NYSTATIN
Nystatin Oral SuspensionNYSTATINXttrium Laboratories, Inc.4a670371-d373-1ba6-e063-6394a90a13b62026-02-06Adverse reactionsName fallback
generic name: NYSTATIN
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0007NystatinnystatinE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
42254-284NystatinnystatinRebel Distributors CorpANDACurrent
50436-1425NystatinnystatinUnit Dose ServicesANDACurrent