U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090834
Company: SAGENT PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/12/2013 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
07/10/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

OCTREOTIDE ACETATE (PRESERVATIVE FREE)

INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204669 HERITAGE PHARMS
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 MEITHEAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077457 FRESENIUS KABI USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079198 MYLAN INSTITUTIONAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090834 SAGENT PHARMS INC
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076313 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

INJECTABLE;INJECTION; EQ 0.1MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216839 GLAND PHARMA LTD
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204669 HERITAGE PHARMS
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 MEITHEAL
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 217860 SHUANGCHENG
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077457 FRESENIUS KABI USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079198 MYLAN INSTITUTIONAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090834 SAGENT PHARMS INC
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076313 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

INJECTABLE;INJECTION; EQ 0.5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216839 GLAND PHARMA LTD
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204669 HERITAGE PHARMS
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 MEITHEAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077457 FRESENIUS KABI USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079198 MYLAN INSTITUTIONAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090834 SAGENT PHARMS INC
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076313 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS
Back to Top