FDA.reportPublic FDA data

Application 204785

Type
ANDA
Sponsor
WRASER PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREZIXACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATECAPSULE;ORAL320.5MG;30MG;16MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42195-840Acetaminophen, Caffeine, Dihydrocodeine BitartrateAcetaminophen, Caffeine, Dihydrocodeine BitartrateXSPIRE PHARMA LLCANDACurrent
42195-840Acetaminophen, Caffeine, Dihydrocodeine BitartrateAcetaminophen, Caffeine, Dihydrocodeine BitartrateXspire Pharma, LlcANDACurrent
42195-840Acetaminophen, Caffeine, Dihydrocodeine BitartrateAcetaminophen, Caffeine, Dihydrocodeine BitartrateXspire Pharma, LlcANDACurrent
63187-705Trezixacetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDACurrent
63187-705Trezixacetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDACurrent
63187-705Trezixacetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDACurrent
63187-705Trezixacetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDACurrent
63629-5637Trezixacetaminophen, caffeine, dihydrocodeine bitartrateBryant Ranch PrepackANDACurrent
63629-5637Trezixacetaminophen, caffeine, dihydrocodeine bitartrateBryant Ranch PrepackANDACurrent
63629-5637Trezixacetaminophen, caffeine, dihydrocodeine bitartrateBryant Ranch PrepackANDACurrent
66992-840Trezixacetaminophen, caffeine, dihydrocodeine bitartrateWraser LlcANDACurrent
66992-840Trezixacetaminophen, caffeine, dihydrocodeine bitartrateWraSer LLCANDACurrent
66992-840Trezixacetaminophen, caffeine, dihydrocodeine bitartrateWraSer LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76464ORIG 2023-11-07
40421ORIG2014-12-19
10394ORIG2014-12-03