FDA.reportPublic FDA data

Application 040608

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL300MG;2.5MGNoYes
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL300MG;5MGNoYes
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL300MG;7.5MGNoYes
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL300MG;10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24090-681Primlevoxycodone and acetaminophenAkrimax Pharmaceuticals, LLCANDACurrent
24090-681Primlevoxycodone and acetaminophenAkrimax Pharmaceuticals, LLCANDACurrent
24090-682Primlevoxycodone and acetaminophenAkrimax Pharmaceuticals, LLCANDACurrent
24090-682Primlevoxycodone and acetaminophenAkrimax Pharmaceuticals, LLCANDACurrent
24090-683Primlevoxycodone and acetaminophenAkrimax Pharmaceuticals, LLCANDACurrent
24090-683Primlevoxycodone and acetaminophenAkrimax Pharmaceuticals, LLCANDACurrent
46672-193oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-193oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-193oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-193oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-194oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-194oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-194oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-194oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-195oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-195oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-195oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-195oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-196oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-196oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-196oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
46672-196oxycodone and acetaminophenoxycodone and acetaminophenMikart, LLCANDACurrent
72245-193Nalocetoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-193Nalocetoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-193Nalocetoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-681Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-681Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-681Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-681Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-682Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-682Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-682Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-682Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-683Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-683Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-683Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72245-683Prolateoxycodone and acetaminophenForte Bio-Pharma LLCANDACurrent
72887-193oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-193oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-193oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-193oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-193oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-193oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-681oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-681oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-681oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-681oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-681oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-682oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-682oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-682oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-682oxycodone and acetaminophenoxycodone and acetaminophenFH2 Pharma LLCANDACurrent
72887-683oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-683oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-683oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-683oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent
72887-683oxycodone and acetaminophenoxycodone and acetaminophen tabletsFH2 Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76121ORIG 2023-11-03