FDA.reportPublic FDA data

Application 071258

Type
ANDA
Sponsor
APOTEX

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
A071258-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071258-001AB

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 22:54:322026-06A071258-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071258-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEApotex Corp71961ab1-951d-1493-f76c-2ff25cca2a852026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071258
application number: ANDA071258
ndc (product): 60505-2653
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5d22a06c-9cb8-4b49-8d67-769d181ad70c2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071258
application number: ANDA071258
ndc (product): 71610-514

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6554Trazodone HydrochlorideTrazodone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6554Trazodone HydrochlorideTrazodone HydrochlorideMajor PharmaceuticalsANDACurrent
50090-2372Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2372Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2372Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2372Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2852Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
55154-7644Trazodone HydrochlorideTrazodone HydrochlorideCardinal HealthANDACurrent
55154-7644Trazodone HydrochlorideTrazodone HydrochlorideCardinal HealthANDACurrent
60429-187Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-187Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-187Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-187Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-187Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60505-2653Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2653Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2653Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2653Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
68071-3099Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
70518-1410Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0035Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0035Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71610-514Trazodone HydrochlorideTrazodone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53957ORIG2018-05-01
39429SUPPL2013-11-20
8405SUPPL2013-11-20