FDA.reportPublic FDA data

Application 064022

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATINNYSTATINCREAM;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
A064022-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATRS1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064022-001AT

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 22:54:322026-06A064022-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATRS1993-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064022-001AT1a50c72e98297…

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
NystatinNYSTATINSun Pharmaceutical Industries, Inc.4d845b3f-ca26-4c47-b424-b6d783cc10e52025-07-03Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
ndc (product): 51672-1289
NystatinNYSTATINNuCare Pharmaceuticals,Inc.cf6b7c68-7769-1808-e053-2995a90aa4262025-02-10Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
ndc (product): 68071-2556
NYSTATINNYSTATINDIRECT RXcd387929-5b72-e3c0-e053-2a95a90adb222025-01-20Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
ndc (product): 72189-278
NystatinNYSTATINNuCare Pharmaceuticals,Inc.57825c04-dcb5-b76d-e053-2991aa0a4c1d2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
ndc (product): 66267-952
NystatinNYSTATINProficient Rx LP5ef15e1c-66dc-4858-8552-d83e42c3883e2019-11-01Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
ndc (product): 63187-703

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-761NystatinNystatinRebel Distributors CorpANDACurrent
51672-1289NystatinNystatinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1289NystatinNystatinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
63187-703NystatinNystatinProficient Rx LPANDACurrent
63187-703NystatinNystatinProficient Rx LPANDACurrent
66267-952NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-952NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2556NystatinNystatinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7366NystatinNystatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7949NystatinNystatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7949NystatinNystatinPreferred Pharmaceuticals Inc.ANDACurrent
72189-278NYSTATINNYSTATINDIRECT RXANDACurrent
72189-278NYSTATINNYSTATINDIRECT RXANDACurrent