Last Updated: August 2, 2026

Details for New Drug Application (NDA): 091041

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NDA 091041 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Gland, Heritage, Meitheal, Mylan Labs Ltd, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional, and is included in twenty-three NDAs. It is available from nine suppliers. Additional details are available on the OCTREOTIDE ACETATE profile page.

The generic ingredient in OCTREOTIDE ACETATE is octreotide acetate. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

Summary for 091041

Tradename:	OCTREOTIDE ACETATE
Applicant:	Sagent Pharms Inc
Ingredient:	octreotide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 091041

Antineoplastic Agents, Hormonal
Gastrointestinal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.2MG BASE/ML
Approval Date:	Nov 12, 2013	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Nov 12, 2013	TE:	AP	RLD:	No

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