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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204785-001TREZIXACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrezixACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEProficient Rx LP45c3c2a1-6a89-471e-b6d4-5a4cd73b987a2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204785
application number: ANDA204785
ndc (product): 63187-705

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

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