FDA.reportPublic FDA data

Application 061966

Type
ANDA
Sponsor
ACP NIMBLE

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
A061966-001NYSTATINNYSTATIN100,000 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
A061966-001AT

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 22:54:322026-06A061966-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A061966-001AT1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINA-S Medication Solutions98bd8ccb-0c68-47b9-bcb4-c5d8217868d92026-07-24Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
ndc (product): 50090-3799
NystatinNYSTATIN CREAMNuCare Pharmaceuticals, Inc.42f21220-c68a-d748-e063-6394a90a1e2f2025-11-06Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATINA-S Medication Solutionsa1b5ccb2-d0d6-46cc-b792-6920b50d0a032025-05-15Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
ndc (product): 50090-3772
NystatinNYSTATIN CREAMCosette Pharmaceuticals, Inc.ec1b52af-d38e-eba1-e63c-dba4341d3af22022-11-22Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
ndc (product): 0713-0678
NystatinNYSTATIN CREAMProficient Rx LPb1efcc2c-f71a-463d-9a02-fad7550f31ec2022-11-01Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
ndc (product): 71205-723

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0678NystatinNystatin CreamG&W Laboratories, Inc.ANDACurrent
0713-0678NystatinNystatin CreamCosette Pharmaceuticals, Inc.ANDACurrent
0713-0678NystatinNystatin CreamCosette Pharmaceuticals, Inc.ANDACurrent
0713-0678NystatinNystatin CreamCosette Pharmaceuticals, Inc.ANDACurrent
50090-3772NystatinNystatinA-S Medication SolutionsANDACurrent
50090-3772NystatinNystatinA-S Medication SolutionsANDACurrent
50090-3772NystatinNystatinA-S Medication SolutionsANDACurrent
50090-3799NystatinNystatinA-S Medication SolutionsANDACurrent
68071-2483NystatinNystatin CreamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2658NystatinNystatin CreamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7513NystatinNystatin CreamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7513NystatinNystatin CreamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7513NystatinNystatin CreamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8234NystatinNystatin CreamPreferred Pharmaceuticals, Inc.ANDACurrent
71205-723NystatinNystatin CreamProficient Rx LPANDACurrent
72189-046NYSTATINNYSTATINDirect_RxANDACurrent