FDA.reportPublic FDA data

Application 208042

Type
NDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CASSIPABUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEFILM;SUBLINGUALEQ 16MG BASE;EQ 4MG BASEYesNo

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
N208042-001CASSIPABUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 16MG BASE;EQ 4MG BASEFILM / SUBLINGUALRLD2018-09-07

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 UTC2022-10N208042-001CASSIPAEQ 16MG BASE;EQ 4MG BASEFILM / SUBLINGUALRLD2018-09-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208042-001CASSIPAEQ 16MG BASE;EQ 4MG BASEFILM / SUBLINGUALRLD2018-09-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208042-001CASSIPAEQ 16MG BASE;EQ 4MG BASEFILM / SUBLINGUALRLD2018-09-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208042-001CASSIPAEQ 16MG BASE;EQ 4MG BASEFILM / SUBLINGUALRLD2018-09-07a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77896SUPPL 2024-03-21
77079SUPPL 2023-12-19
76938SUPPL 2023-12-18
76937SUPPL 2023-12-18
76391ORIG 2023-11-06
73856SUPPL 2023-03-24
73838SUPPL 2023-03-24
73837SUPPL 2023-03-24
73064SUPPL2022-12-29
71402SUPPL2022-06-21
71401SUPPL2022-06-21
71381SUPPL2022-06-21
71380SUPPL2022-06-21
70982SUPPL2022-05-04
66615SUPPL2021-03-08
66538SUPPL2021-03-05
66537SUPPL2021-03-05
60486SUPPL2019-10-09
60485SUPPL2019-10-09
60464SUPPL2019-10-09
58461ORIG2019-04-29
57216APPL2019-01-14
55438ORIG2018-09-12
55414ORIG2018-09-10