FDA.reportPublic FDA data

Application 062512

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

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

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
A062512-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062512-001AA

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 22:54:322026-06A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062512-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin Oral SuspensionNYSTATINXttrium Laboratories, Inc.4a670371-d373-1ba6-e063-6394a90a13b62026-02-06Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512
NystatinNYSTATINA-S Medication Solutionse069d495-7f1a-4970-8f4d-aa93d124b3fc2023-02-04Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512
ndc (product): 50090-1740

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4785NystatinNystatinPharmaceutical Associates, Inc.ANDACurrent
17856-0037NystatinNystatinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0538NystatinNystatinATLANTIC BIOLOGICALS CORP.ANDACurrent
42254-067NystatinNystatinRebel Distributors CorpANDACurrent
50090-1740NystatinnystatinA-S Medication SolutionsANDACurrent
55154-1578NystatinNystatinCardinal Health 107, LLCANDACurrent
55154-1578NystatinNystatinCardinal HealthANDACurrent
55154-1578NystatinNystatinCardinal HealthANDACurrent
55154-1578NystatinNystatinCardinal HealthANDACurrent
60432-537NystatinnystatinMorton Grove Pharmaceuticals, Inc.ANDACurrent
63629-2598NystatinNystatinBryant Ranch PrepackANDACurrent
63739-634NystatinNystatinMcKesson CorporationANDACurrent
63739-634NystatinnystatinMcKesson Corporation dba SKY PackagingANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68094-599NystatinNystatinPrecision Dose, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6792NystatinNystatinPreferred Pharmaceuticals, Inc.ANDACurrent