FDA.reportPublic FDA data

Application 040885

Type
ANDA
Sponsor
NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL300MG;50MG;40MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
0722-7029Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine CapsulesNexgen Pharma, Inc.ANDACurrent
0722-7029Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine CapsulesNexgen Pharma, Inc.ANDACurrent
42291-181Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineAvKAREANDACurrent
42291-181Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineAvKAREANDACurrent
42291-181Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineAvKARE, Inc.ANDACurrent
42291-181Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineAvKARE, Inc.ANDACurrent
52544-080FioricetButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
52544-080FioricetButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
52544-080FioricetButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
52544-080FioricetButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
52544-080FioricetButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
59702-661ORBIVANButalbital, Acetaminophen, and CaffeineAtley Pharmaceuticals, Inc.ANDACurrent
65084-454FioricetButalbital, Acetaminophen, and CaffeineMckesson Rxpak IncANDACurrent
65084-454FioricetButalbital, Acetaminophen, and CaffeineMcKesson Corporation dba RX PakANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62273ORIG2020-03-24