FDA.reportPublic FDA data

Application 204209

Type
ANDA
Sponsor
LARKEN LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATEACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATETABLET;ORAL325MG;30MG;16MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68047-720Acetaminophen, Caffeine and Dihydrocodeine BitartrateAcetaminophen, Caffeine and Dihydrocodeine BitartrateLarken Laboratories Inc.ANDACurrent
68047-720Acetaminophen, Caffeine and Dihydrocodeine BitartrateAcetaminophen, Caffeine and Dihydrocodeine BitartrateLarken Laboratories Inc.ANDACurrent
68047-720Acetaminophen, Caffeine and Dihydrocodeine BitartrateAcetaminophen, Caffeine and Dihydrocodeine BitartrateLarken Laboratories Inc.ANDACurrent
70362-730DVORAHacetaminophen, caffeine and dihydrocodeine bitartrateSkylar Laboratories, LLCANDACurrent
70362-730DVORAHacetaminophen, caffeine and dihydrocodeine bitartrateSkylar Laboratories, LLCANDACurrent
70362-730DVORAHacetaminophen, caffeine and dihydrocodeine bitartrateSkylar Laboratories, LLCANDACurrent
70569-152DVORAHacetaminophen, caffeine and dihydrocodeine bitartratePhlight Pharma, LLCANDACurrent
70569-152DVORAHacetaminophen, caffeine and dihydrocodeine bitartratePhlight Pharma, LLCANDACurrent
71993-300Acetaminophen, Caffeine and Dihydrocodeine BitartrateAcetaminophen, Caffeine and Dihydrocodeine BitartrateAtland Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76103ORIG 2023-11-02
45590ORIG2016-10-05