FDA.reportPublic FDA data

Application 091632

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLNoNo

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
A091632-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALRS2010-10-01

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 UTC2022-10A091632-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALAB2010-10-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091632-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALAB2010-10-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091632-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALAB2010-10-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091632-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALRS2010-10-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091632-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091632-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091632-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091632-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091632-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091632-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091632-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091632-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091632-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091632-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091632-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091632-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091632-001AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091632-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091632-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091632-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091632-001AB1cb3db0bc1861…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releaseHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXBryant Ranch Prepacke0010aac-2d7e-4dd3-8024-ff0c7f668b772025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091632
application number: ANDA091632
ndc (product): 63629-2303
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releaseHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXCranbury Pharmaceuticals, LLC25f400d9-1d6e-4d38-8f0d-98d471eba73b2024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091632
application number: ANDA091632
ndc (product): 27808-086
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releaseHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXBryant Ranch Prepackeecaa52b-f636-4ae4-a60f-d5e2503ab53b2023-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091632
application number: ANDA091632
ndc (product): 63629-2304

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0235Hydrocodone Polistirex and Chlorpheniramine PolisitrexHydrocodone Polistirex and Chlorpheniramine PolisitrexAtlantic Biologicals CorpsANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43255ORIG2013-02-01