FDA.reportPublic FDA data

Application 019194

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYPRINETRIENTINE HYDROCHLORIDECAPSULE;ORAL250MGYesYes

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
N019194-001SYPRINETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALABRLD, RS1985-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019194-001AB

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 22:54:322026-06N019194-001SYPRINE250MGCAPSULE / ORALABRLD, RS1985-11-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019194-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SyprineTRIENTINE HYDROCHLORIDEBausch Health US LLCc34f77a7-996b-4470-b5df-d946a7fe5dbe2020-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 019194
application number: NDA019194
ndc (product): 0187-2120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-2120Syprinetrientine hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health US LLCNDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health US LLCNDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health US LLCNDACurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20212SUPPL2001-06-08
57418ORIG1985-10-31