FDA.reportPublic FDA data

Application 020451

Type
NDA
Sponsor
PINNACLE BIOLGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHOTOFRINPORFIMER SODIUMINJECTABLE;INJECTION75MG/VIALNoNo

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
N020451-001PHOTOFRINPORFIMER SODIUM75MG/VIALINJECTABLE / INJECTION1995-12-27

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 UTC2022-10N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27a50c72e98297…

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
PhotofrinPORFIMER SODIUMPinnacle Biologics, Inc.5c4841b4-fbc0-4163-8ee1-cb28629cbfbf2026-04-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 020451
application number: NDA020451
ndc (product): 76128-155

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent
76128-155PhotofrinPorfimer SodiumPinnacle Biologics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61516SUPPL2020-01-06
61491SUPPL2020-01-02
57647ORIG2019-02-15
24992SUPPL2011-07-05
34675SUPPL2011-06-28
2561SUPPL2011-04-06
12603SUPPL2011-04-04
34674SUPPL2008-09-09
2560SUPPL2008-09-09
41377SUPPL2006-07-25
2559SUPPL2005-10-20
24991SUPPL2003-08-15
12602SUPPL2003-08-14
2558SUPPL1998-12-22
2557SUPPL1998-01-09