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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217860

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NDA 217860 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 217860

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

Pharmacology for NDA: 217860

Mechanism of Action	Somatostatin Receptor Agonists

Medical Subject Heading (MeSH) Categories for 217860

Antineoplastic Agents, Hormonal
Gastrointestinal Agents

Suppliers and Packaging for NDA: 217860

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	217860	ANDA	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-046	52958-046-10	10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.1MG BASE/ML
Approval Date:	May 2, 2024	TE:		RLD:	No

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