FDA.reportPublic FDA data

Application 202142

Type
ANDA
Sponsor
MIKART INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDESOLUTION;ORAL300MG/5ML;10MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202142-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE300MG/5ML;10MG/5MLSOLUTION / ORAL2018-11-27

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A202142-001OXYCODONE AND ACETAMINOPHEN300MG/5ML;10MG/5MLSOLUTION / ORAL2018-11-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202142-001OXYCODONE AND ACETAMINOPHEN300MG/5ML;10MG/5MLSOLUTION / ORAL2018-11-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202142-001OXYCODONE AND ACETAMINOPHEN300MG/5ML;10MG/5MLSOLUTION / ORAL2018-11-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202142-001OXYCODONE AND ACETAMINOPHEN300MG/5ML;10MG/5MLSOLUTION / ORAL2018-11-27a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProlateOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENForte Bio-Pharma LLC9d75ad3b-bc9b-0c22-e053-2a95a90ac71e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202142
application number: ANDA202142
ndc (product): 72245-648
oxycodone hydrochloride and acetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENFH2 Pharma LLC96b0067e-aabe-df4f-e053-2995a90a4a862026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202142
application number: ANDA202142
ndc (product): 72887-648

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenMikart, LLCANDACurrent
46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenMikart, LLCANDACurrent
46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenMikart, LLCANDACurrent
46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenMikart, LLCANDACurrent
46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenMikart, LLCANDACurrent
72245-648Prolateoxycodone hydrochloride and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-648Prolateoxycodone hydrochloride and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-648Prolateoxycodone hydrochloride and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-648Prolateoxycodone hydrochloride and acetaminophenForte Bio-Pharma LLCANDACurrent
72887-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenFH2 Pharma LLCANDACurrent
72887-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenFH2 Pharma LLCANDACurrent
72887-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenFH2 Pharma LLCANDACurrent
72887-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophenFH2 Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76431ORIG 2023-11-07
56845ORIG2018-12-20