FDA.reportPublic FDA data

Application 090956

Type
ANDA
Sponsor
NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL300MG;50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0095-3000BUPAPButalbital and Acetaminophen TabletsBausch Health US, LLCANDACurrent
0095-3000BUPAPButalbital and Acetaminophen TabletsECR PharmaceuticalsANDACurrent
0095-3000BUPAPButalbital and Acetaminophen TabletsBausch Health Americas Inc.ANDACurrent
0095-3000BUPAPButalbital and Acetaminophen TabletsBausch Health US, LLCANDACurrent
0095-3000BUPAPButalbital and Acetaminophen TabletsBausch Health US, LLCANDACurrent
0722-7075Butalbital and AcetaminophenButalbital and AcetaminophenNexgen Pharma, Inc.ANDACurrent
0722-7075Butalbital and AcetaminophenButalbital and AcetaminophenNexgen Pharma, Inc.ANDACurrent
68682-306Butalbital and AcetaminophenButalbital and Acetaminophen tabletsOceanside PharmaceuticalsANDACurrent
68682-306Butalbital and AcetaminophenButalbital and Acetaminophen tabletsOceanside PharmaceuticalsANDACurrent
68682-306Butalbital and AcetaminophenButalbital and Acetaminophen tabletsOceanside PharmaceuticalsANDACurrent
68682-306Butalbital and AcetaminophenButalbital and Acetaminophen tabletsOceanside PharmaceuticalsANDACurrent
79739-7075Butalbital and AcetaminophenButalbital and AcetaminophenLGM Pharma Solutions, LLCANDACurrent