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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075959

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NDA 075959 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Gland, Heritage, Meitheal, 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-two 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. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

Summary for 075959

Tradename:	OCTREOTIDE ACETATE
Applicant:	Meitheal
Ingredient:	octreotide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075959

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 21, 2005	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 21, 2005	TE:	AP	RLD:	No

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