FDA.reportPublic FDA data

Application 075231

Type
ANDA
Sponsor
NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORAL325MG;50MG;40MG;30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0722-6094Ascomp with CodeineButalbital, Aspirin, Cafeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-6094Ascomp with CodeineButalbital, Aspirin, Cafeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
0722-6094Ascomp with CodeineButalbital, Aspirin, Cafeine, and Codeine PhosphateNexgen Pharma, Inc.ANDACurrent
51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-074Ascomp with CodeineBUTALBITAL, ASPIRIN, CAFFEINE, and CODEINE PHOSPHATEBRECKENRIDGE PHARMACEUTICAL, INC.ANDACurrent
51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.ANDACurrent
63629-2952BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEButalbital, Aspirin, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-2952BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEButalbital, Aspirin, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-2952BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEButalbital, Aspirin, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-2952BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEButalbital, Aspirin, Caffeine and Codeine PhosphateBryant Ranch PrepackANDACurrent
79739-6094Ascomp with CodeineButalbital, Aspirin, Cafeine, and Codeine PhosphateLGM Pharma Solutions, LLCANDACurrent
79739-6094Ascomp with CodeineButalbital, Aspirin, Cafeine, and Codeine PhosphateLGM PHARMA SOLUTIONS, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76126ORIG 2023-11-03
30805ORIG2003-04-10