FDA.reportPublic FDA data

Application 071196

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL100MGNoYes
002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL150MGNoNo
003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL300MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071196-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25
A071196-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26
A071196-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071196-001AB
A071196-002AB
A071196-003AB

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 22:54:322026-06A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25a50c72e98297…
2026-08-01 22:54:322026-06A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26a50c72e98297…
2026-08-01 22:54:322026-06A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071196-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A071196-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A071196-003AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.dc1f347e-1acb-4c06-b36e-f15fecb7ac932026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
ndc (product): 70518-3403
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEApotex Corp71961ab1-951d-1493-f76c-2ff25cca2a852026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
ndc (product): 60505-2655
ndc (product): 60505-2654
ndc (product): 60505-4089
ndc (product): 60505-2659
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5d22a06c-9cb8-4b49-8d67-769d181ad70c2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
ndc (product): 71610-513
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9c4da6ad-d4d1-4e8c-918d-8ac48512a93f2020-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
ndc (product): 0555-0711

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0711Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0711Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0733Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0733Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0733Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0733Trazodone HydrochlorideTrazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0904-6555Trazodone HydrochlorideTrazodone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6555Trazodone HydrochlorideTrazodone HydrochlorideMajor PharmaceuticalsANDACurrent
10544-867Trazodone HydrochlorideTrazodone HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
50090-2373Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2373Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2373Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2373Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2373Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2373Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2374Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2374Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2374Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2374Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2374Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2759Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50268-771Trazodone HydrochlorideTrazodone HydrochlorideAvPAKANDACurrent
55154-7642Trazodone HydrochlorideTrazodone HydrochlorideCardinal HealthANDACurrent
55154-7642Trazodone HydrochlorideTrazodone HydrochlorideCardinal HealthANDACurrent
55700-645Trazodone HydrochlorideTrazodone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-188Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-188Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-188Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-188Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-230Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-230Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-230Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-230Trazodone HydrochlorideTrazodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60505-2654Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2654Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2654Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2654Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2655Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2655Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2655Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2655Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2659Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2659Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2659Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-2659Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-4089Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-4089Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-4089Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
60505-4089Trazodone HydrochlorideTrazodone HydrochlorideApotex CorpANDACurrent
63629-7287Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7287Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7287Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
68071-3256Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68084-608Trazodone HydrochlorideTrazodone HydrochlorideAmerican Health PackagingANDACurrent
68084-608Trazodone HydrochlorideTrazodone HydrochlorideAmerican Health PackagingANDACurrent
68788-7004Trazodone HydrochlorideTrazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7004Trazodone HydrochlorideTrazodone HydrochloridePreferred PharmaceuticalsANDACurrent
70518-1195Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1195Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3403Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0164Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0164Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0343Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0343Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0773Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0773Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71610-513Trazodone HydrochlorideTrazodone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53958ORIG2018-05-01
47233SUPPL2017-02-16
47232SUPPL2017-02-16
39428SUPPL2013-11-20
8404SUPPL2013-11-20