FDA.reportPublic FDA data

Application 206615

Type
ANDA
Sponsor
WRASER PHARMS LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineXspire Pharma, LLCANDACurrent
66992-955Phrenilin ForteButalbital, Acetaminophen, CaffeineWraser LLCANDACurrent
71205-962Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineProficient Rx LPANDACurrent
71205-962Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineProficient Rx LPANDACurrent