FDA.reportPublic FDA data

Application 073137

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL100MGNoNo
002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL50MGNoNo
003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL150MGNoNo

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
A073137-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24
A073137-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24
A073137-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073137-001AB
A073137-002AB
A073137-003AB

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 22:54:322026-06A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073137-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-003AB1a50c72e98297…

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 HYDROCHLORIDECoupler LLC55f18806-6c23-783b-e063-6294a90acc462026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC4c4ca53e-9201-298c-e063-6294a90a72c62026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.fa7afa93-b98c-4dc7-bbb8-ab6a058427b92025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.f291b905-a739-5e43-e053-2995a90ac40c2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2211Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2393Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2529Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
53489-510Trazodone HydrochlorideTrazodone HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
53489-511Trazodone HydrochlorideTrazodone HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
53489-517Trazodone HydrochlorideTrazodone HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
66116-357Trazodone HydrochlorideTrazodone HydrochlorideMedVantx, Inc.ANDACurrent
70518-1287Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent