FDA.reportPublic FDA data

Application 091671

Type
ANDA
Sponsor
NEOS THERAP INC

Application Products#

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

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
A091671-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREXCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-06-29

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 UTC2022-10A091671-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALABRS2012-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091671-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALABRS2012-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091671-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORALABRS2012-06-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091671-001HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREXEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-06-29a50c72e98297…

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 ZIP2022-06A091671-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091671-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091671-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091671-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091671-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091671-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091671-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091671-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091671-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091671-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091671-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091671-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091671-001AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091671-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091671-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091671-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091671-001AB1cb3db0bc1861…

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexAtlantic Biologicals CorpsANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics, LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics, LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics, LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics LPANDACurrent
62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexNeos Therapeutics LPANDACurrent