← FDA DRUG APPROVALS

FDA ANDA · ANDA077372

OCTREOTIDE ACETATE

Sponsor: SUN PHARM INDS

APPLICATION
ANDA077372
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-14
LATEST ACTION
2017-06-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OCTREOTIDE ACETATEDiscontinued
OCTREOTIDE ACETATE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATEDiscontinued
OCTREOTIDE ACETATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATEDiscontinued
OCTREOTIDE ACETATE EQ 0.1MG BASE/ML · INJECTABLE · INJECTION

Approval history

2017-06-28Labeling · Supplement 10 · standardAP
2013-01-31Labeling · Supplement 6 · standardAP
2012-11-30Labeling · Supplement 4 · standardAP
2007-08-14OriginalAP
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 →