FDA — authorised 28 March 2005
- Application: ANDA076313
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Sandostatine® in United States
FDA authorised Sandostatine® on 28 March 2005
Marketing authorisations
FDA — authorised 8 April 2005
- Application: ANDA076330
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 October 2005
- Application: ANDA075957
- Marketing authorisation holder: MEITHEAL
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 November 2005
- Application: ANDA075959
- Marketing authorisation holder: MEITHEAL
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 February 2006
- Application: ANDA077457
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 February 2006
- Application: ANDA077450
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 August 2007
- Application: ANDA077372
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 August 2007
- Application: ANDA077373
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 2008
- Application: ANDA077330
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 2008
- Application: ANDA077329
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 2008
- Application: ANDA077331
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 February 2011
- Application: ANDA079198
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 2011
- Application: ANDA090986
- Marketing authorisation holder: WOCKHARDT USA
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 2011
- Application: ANDA090985
- Marketing authorisation holder: WOCKHARDT USA
- Local brand name: OCTREOTIDE ACETATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 November 2013
- Application: ANDA090834
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 September 2018
- Application: ANDA203765
- Marketing authorisation holder: HERITAGE
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 June 2023
- Application: ANDA216839
- Marketing authorisation holder: GLAND
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 December 2023
- Application: ANDA210317
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 May 2024
- Application: ANDA217860
- Marketing authorisation holder: SHUANGCHENG
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 September 2024
- Application: NDA213224
- Marketing authorisation holder: SUN PHARM
- Local brand name: BYNFEZIA PEN
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 12 December 2025
- Application: ANDA216589
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: OCTREOTIDE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is Sandostatine® approved in United States?
Yes. FDA authorised it on 28 March 2005; FDA authorised it on 8 April 2005; FDA authorised it on 3 October 2005.
Who is the marketing authorisation holder for Sandostatine® in United States?
WEST-WARD PHARMS INT holds the US marketing authorisation.