FDA.reportPublic FDA data

Application 076560

Type
ANDA
Sponsor
NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORAL325MG;50MG;40MG;30MGNoNo
002BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORAL300MG;50MG;40MG;30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2641Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
0591-2641Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
0591-2641Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
0591-2641Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
0591-2641Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
0722-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
51991-073Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-073Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-073Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-073Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-073Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
52544-082Fioricet with CodeineButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
52544-082Fioricet with CodeineButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
52544-082Fioricet with CodeineButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
52544-082Fioricet with CodeineButalbital, Acetaminophen, Caffeine, and Codeine PhosphateActavis Pharma, Inc.ANDACurrent
68258-2012Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateDispensing Solutions, Inc.ANDACurrent
71335-0194Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
71335-0194Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
71335-0194Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
79739-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateLGM Pharma Solutions LLCANDACurrent
79739-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateLGM Pharma Solutions, LLCANDACurrent
79739-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateLGM Pharma Solutions, LLCANDACurrent
79739-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine PhosphateLGM Pharma Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76125ORIG 2023-11-03