Orange Book product · Brand (NDA)
SANDOSTATIN
OCTREOTIDE ACETATE
At a glance
Jun 12, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 1991
35 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
OCTREOTIDE ACETATE
Strength
EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019667
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024BYNFEZIA PENBrand (NDA)
NDA 213224 · SUN PHARM
- 2020MYCAPSSABrand (NDA)
NDA 208232 · CHIESI
- 1998SANDOSTATIN LARBrand (NDA)
NDA 021008 · NOVARTIS
- 2025OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 216589 · MYLAN LABS LTD
- 2024OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 217860 · SHUANGCHENG
- 2023OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 210317 · TEVA PHARMS USA INC
- 2023OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 216839 · GLAND
- 2023OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 216807 · GLAND
- 2018OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 204669 · HERITAGE
- 2018OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 203765 · HERITAGE
- 2013OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 091041 · SAGENT PHARMS INC
- 2013OCTREOTIDE ACETATE (PRESERVATIVE FREE)Generic (ANDA)
ANDA 090834 · SAGENT PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
