FDA.reportPublic FDA data

Application 018074

Type
NDA
Sponsor
VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL105MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018074-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018074-001PHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018074-001PHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018074-001PHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018074-001PHENDIMETRAZINE TARTRATE105MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS, Approved before 1982a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEAcertis Pharmaceuticals, LLC162140d3-b833-4633-9759-95821a46a6902025-12-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 018074
application number: NDA018074
ndc (product): 72989-409

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-5254Phendimetrazine TartratePhendimetrazine TartrateEon Labs, Inc.NDACurrent
12634-910Phendimetrazine TartratePhendimetrazine TartrateApotheca Inc.NDACurrent
17224-831PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATECALVIN, SCOTT AND COMPANY, INCORPORATEDNDACurrent
33261-390Phendimetrazine TartratePhendimetrazine TartrateAidarex Pharmaceuticals LLCNDACurrent
43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.NDACurrent
50090-0338Phendimetrazine TartratePhendimetrazine TartrateA-S Medication SolutionsNDACurrent
50090-3988PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEA-S Medication SolutionsNDACurrent
50090-3988PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEA-S Medication SolutionsNDACurrent
50090-3988PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEA-S Medication SolutionsNDACurrent
52959-886PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEH.J. Harkins Company, Inc.NDACurrent
63629-3051Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackNDACurrent
63629-3051Phendimetrazine TartratePhendimetrazine TartrateBryant Ranch PrepackNDACurrent
68071-3040Phendimetrazine TartratePhendimetrazine TartrateNuCare Pharmaceuticals, Inc.NDACurrent
68071-3040Phendimetrazine TartratePhendimetrazine TartrateNuCare Pharmaceuticals, Inc.NDACurrent
69543-409PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCNDACurrent
69543-409PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCNDACurrent
69543-409PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCNDACurrent
69543-409PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCNDACurrent
69543-413FENDIQUE ERPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCNDACurrent
69543-413FENDIQUE ERPHENDIMETRAZINE TARTRATEVirtus Pharmaceuticals, LLCNDACurrent
72989-409PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEAcertis Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67015SUPPL2021-04-09
58077SUPPL2019-03-26
58072SUPPL2019-03-25
33411SUPPL2012-02-24
819SUPPL2012-02-14