FDA.reportPublic FDA data

Application 077273

Type
ANDA
Sponsor
ECR PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TUSSICAPSCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXCAPSULE, EXTENDED RELEASE;ORALEQ 8MG MALEATE;EQ 10MG BITARTRATENoYes
002TUSSICAPSCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXCAPSULE, EXTENDED RELEASE;ORALEQ 4MG MALEATE;EQ 5MG BITARTRATENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077273-001TUSSICAPSCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXEQ 8MG MALEATE;EQ 10MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24
A077273-002TUSSICAPSCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXEQ 4MG MALEATE;EQ 5MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077273-001TUSSICAPSEQ 8MG MALEATE;EQ 10MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077273-002TUSSICAPSEQ 4MG MALEATE;EQ 5MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077273-001TUSSICAPSEQ 8MG MALEATE;EQ 10MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24e64feba35796…
2022-09-29 23:25 UTC2022-09A077273-002TUSSICAPSEQ 4MG MALEATE;EQ 5MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077273-001TUSSICAPSEQ 8MG MALEATE;EQ 10MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077273-002TUSSICAPSEQ 4MG MALEATE;EQ 5MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077273-001TUSSICAPSEQ 8MG MALEATE;EQ 10MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077273-002TUSSICAPSEQ 4MG MALEATE;EQ 5MG BITARTRATECAPSULE, EXTENDED RELEASE / ORAL2007-09-24a50c72e98297…

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirexVALEANT PHARMACEUTICALS NORTH AMERICA LLCANDACurrent
0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirexBausch Health US LLCANDACurrent
0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirexBausch Health Americas Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39522ORIG2007-10-04
31215ORIG2007-09-26