Application 018207

Type
NDA
Sponsor
PRAGMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018207-001DESYRELTRAZODONE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N018207-002DESYRELTRAZODONE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N018207-003DESYRELTRAZODONE HYDROCHLORIDE150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-25
N018207-004DESYRELTRAZODONE HYDROCHLORIDE300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N018207-00181338932029-03-13Drug substance, Drug product2015-07-20
N018207-00281338932029-03-13Drug substance, Drug product2015-07-20
N018207-00381338932029-03-13Drug substance, Drug product2015-07-20
N018207-00481338932029-03-13Drug substance, Drug product2015-07-20

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-0784e616aacf4f…
2026-08-18 06:07:402026-07N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-001DESYREL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-002DESYREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-003DESYREL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-004DESYREL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-11-075bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N018207-00181338932029-03-13Drug substance, Drug product2015-07-2084e616aacf4f…
2026-09-14 22:38:342026-08N018207-00281338932029-03-13Drug substance, Drug product2015-07-2084e616aacf4f…
2026-09-14 22:38:342026-08N018207-00381338932029-03-13Drug substance, Drug product2015-07-2084e616aacf4f…
2026-09-14 22:38:342026-08N018207-00481338932029-03-13Drug substance, Drug product2015-07-2084e616aacf4f…
2026-08-18 06:07:402026-07N018207-00181338932029-03-13Drug substance, Drug product2015-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N018207-00281338932029-03-13Drug substance, Drug product2015-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N018207-00381338932029-03-13Drug substance, Drug product2015-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N018207-00481338932029-03-13Drug substance, Drug product2015-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018207-00181338932029-03-13Drug substance, Drug product2015-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018207-00281338932029-03-13Drug substance, Drug product2015-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018207-00381338932029-03-13Drug substance, Drug product2015-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018207-00481338932029-03-13Drug substance, Drug product2015-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-00181338932029-03-13Drug substance, Drug product2015-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-00281338932029-03-13Drug substance, Drug product2015-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-00381338932029-03-13Drug substance, Drug product2015-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018207-00481338932029-03-13Drug substance, Drug product2015-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018207-00181338932029-03-13Drug substance, Drug product2015-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018207-00281338932029-03-13Drug substance, Drug product2015-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018207-00381338932029-03-13Drug substance, Drug product2015-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018207-00481338932029-03-13Drug substance, Drug product2015-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-00181338932029-03-13Drug substance, Drug product2015-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-00281338932029-03-13Drug substance, Drug product2015-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-00381338932029-03-13Drug substance, Drug product2015-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018207-00481338932029-03-13Drug substance, Drug product2015-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-00181338932029-03-13Drug substance, Drug product2015-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-00281338932029-03-13Drug substance, Drug product2015-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-00381338932029-03-13Drug substance, Drug product2015-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018207-00481338932029-03-13Drug substance, Drug product2015-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-00181338932029-03-13Drug substance, Drug product2015-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-00281338932029-03-13Drug substance, Drug product2015-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-00381338932029-03-13Drug substance, Drug product2015-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018207-00481338932029-03-13Drug substance, Drug product2015-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-00181338932029-03-13Drug substance, Drug product2015-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-00281338932029-03-13Drug substance, Drug product2015-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-00381338932029-03-13Drug substance, Drug product2015-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018207-00481338932029-03-13Drug substance, Drug product2015-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-00181338932029-03-13Drug substance, Drug product2015-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-00281338932029-03-13Drug substance, Drug product2015-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-00381338932029-03-13Drug substance, Drug product2015-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018207-00481338932029-03-13Drug substance, Drug product2015-07-205bbf6a4d5a75…

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 6 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9c4da6ad-d4d1-4e8c-918d-8ac48512a93f2020-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAZODONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85061SUPPL 2026-02-18
82660SUPPL 2025-06-25
56052SUPPL2018-10-22
56017SUPPL2018-10-19
56016SUPPL2018-10-19
48907SUPPL2017-07-05
48893SUPPL2017-07-03
48892SUPPL2017-07-03
14946SUPPL2014-07-21
23541ORIG2007-05-09
33456SUPPL2005-01-13
874SUPPL2005-01-13
873SUPPL2004-03-19