FDA.reportPublic FDA data

Application 062832

Type
ANDA
Sponsor
SOCORRO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATINNYSTATINSUSPENSION;ORAL100,000 UNITS/MLNoNo

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
A062832-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062832-001AA

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 22:54:322026-06A062832-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1991-12-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062832-001AA1a50c72e98297…

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
NYSTATINNYSTATINKesin Pharma Corporation50737729-a4a4-e747-e063-6394a90adcc52026-06-30Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINBryant Ranch Prepack4f6f59fb-ae7d-48e5-b23e-a1d92160974f2026-05-11Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINKesin Pharma Corporation43817169-bbe8-58ee-e063-6294a90a12502025-12-11Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINKanchan Healthcare Inc90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a2025-09-12Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINBryant Ranch Prepackb06c65cd-5b65-4bc6-aae9-b9381c6f19482023-01-26Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
ndc (product): 63629-8520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2492NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2492NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2492NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2492NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2493NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2493NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2493NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-2493NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-8520NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
63629-8520NYSTATINNYSTATINBryant Ranch PrepackANDACurrent
75834-235NYSTATINNYSTATINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-235NYSTATINNYSTATINNivagen Pharmaceuticals, Inc.ANDACurrent