FDA.reportPublic FDA data

Application 072192

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL50MGNoNo

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
A072192-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1989-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072192-001AB

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 22:54:322026-06A072192-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1989-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A072192-001AB1a50c72e98297…

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
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEOxford Pharmaceuticals, LLC283c8236-9776-44cb-b7b2-1024689de7362026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072192
application number: ANDA072192

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-6160Trazodone HydrochlorideTrazodone HydrochloridePar PharmaceuticalANDACurrent
0603-6160Trazodone HydrochlorideTrazodone HydrochloridePar PharmaceuticalANDACurrent
12634-193Trazodone HydrochlorideTrazodone HydrochlorideApotheca Inc.ANDACurrent
43353-652Trazodone HydrochlorideTrazodone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-431Trazodone HydrochlorideTrazodone HydrochlorideMedsource PharmaceuticalsANDACurrent
45865-431Trazodone HydrochlorideTrazodone HydrochlorideMedsource PharmaceuticalsANDACurrent
55700-275Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-275Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-386TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEDIRECT RXANDACurrent
63187-680Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63187-680Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
63629-1513Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
66267-392Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-392Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67046-739Trazodone HydrochlorideTrazodone HydrochlorideContract Pharmacy Services-PAANDACurrent
68387-165Trazodone HydrochlorideTrazodone HydrochlorideKeltman Pharmaceuticals Inc.ANDACurrent