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 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-251e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071196-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071196-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071196-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071196-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071196-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071196-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071196-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071196-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071196-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071196-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071196-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071196-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071196-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071196-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071196-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071196-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071196-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071196-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071196-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071196-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071196-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071196-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071196-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071196-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071196-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071196-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071196-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071196-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071196-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071196-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071196-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071196-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071196-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071196-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071196-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071196-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071196-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071196-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071196-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071196-001AB11e350fbaab3a…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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-f15fecb7ac932026-08-07Boxed 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