FDA.reportPublic FDA data

Application 209587

Type
ANDA
Sponsor
NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0722-7320Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineNexgen Pharma, Inc.ANDACurrent
0722-7320Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineNexgen Pharma, Inc.ANDACurrent
0722-7320Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineNexgen Pharma, Inc.ANDACurrent
50268-553Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineAvPAKANDACurrent
50268-553Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineAvPAKANDACurrent
53002-6031Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineRPK Pharmaceuticals, Inc.ANDACurrent
55700-920Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineQuality Care Products, LLCANDACurrent
55700-920Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineQuality Care Products, LLCANDACurrent
68071-2365Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2365Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2365Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7882Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeinePreferred Pharmaceuticals Inc.ANDACurrent
68788-8137Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeinePreferred Pharmaceuticals Inc.ANDACurrent
69367-203Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineWestminster Pharmaceuticals, LLCANDACurrent
69367-203Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineWestminster Pharmaceuticals, LLCANDACurrent
69367-203Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineWestminster Pharmaceuticals, LLCANDACurrent
70518-2995Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
70518-2995Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
71205-510Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
71205-510Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
71205-981Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
71205-981Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
71205-981Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
71335-1764Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
71335-1764Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
71335-1767Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
71335-1767Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
79739-7320Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLGM Pharma Solutions, LLCANDACurrent