FDA.reportPublic FDA data

Application 090453

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDETABLET;ORAL25MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090453-001MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDE5MGTABLET / ORAL2015-03-20
A090453-002MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDE10MGTABLET / ORAL2015-03-20
A090453-003MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDE25MGTABLET / ORALRS2015-03-20

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 22:54:322026-06A090453-001MOLINDONE HYDROCHLORIDE5MGTABLET / ORAL2015-03-20a50c72e98297…
2026-08-01 22:54:322026-06A090453-002MOLINDONE HYDROCHLORIDE10MGTABLET / ORAL2015-03-20a50c72e98297…
2026-08-01 22:54:322026-06A090453-003MOLINDONE HYDROCHLORIDE25MGTABLET / ORALRS2015-03-20a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Molindone HydrochlorideMOLINDONE HYDROCHLORIDEEPIC PHARMA, LLC1275e92f-9573-4d0c-8e77-1c9ac47696d22025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090453
application number: ANDA090453
ndc (product): 42806-336
ndc (product): 42806-337
ndc (product): 42806-338

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-336Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-336Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-337Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-337Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-338Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-338Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent