← FDA DRUG APPROVALS

FDA NDA · NDA208042

CASSIPA

Sponsor: TEVA PHARMS USA

APPLICATION
NDA208042
TYPE
NDA
ORIGINAL APPROVAL
2018-09-07
LATEST ACTION
2024-03-20
ROUTE
SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Discontinued

Products

CASSIPA · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 16MG BASE, NALOXONE HYDROCHLORIDE EQ 4MG BASE · FILM · SUBLINGUAL

Approval history

2024-03-20REMS · Supplement 10 — Letter ↗AP
2023-12-15Labeling · Supplement 11 · standard — Label ↗AP
2023-03-23Labeling · Supplement 9 · standard — Label ↗AP
2022-12-16REMS · Supplement 8 — Letter ↗AP
2022-06-17Labeling · Supplement 7 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 5 · standard — Letter ↗AP
2022-05-03REMS · Supplement 6 — Letter ↗AP
2021-03-04Labeling · Supplement 4 · standard — Label ↗AP
2019-10-07Labeling · Supplement 1 · standard — Letter ↗AP
2018-09-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →