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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077450
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG 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
02/10/2006 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
03/09/2018 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/09/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/30/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

OCTREOTIDE ACETATE

INJECTABLE;INJECTION; EQ 0.2MG 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 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077450 FRESENIUS KABI USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203765 HERITAGE PHARMS
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091041 SAGENT PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075959 TEVA PHARMS USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076330 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; EQ 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 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077450 FRESENIUS KABI USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203765 HERITAGE PHARMS
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091041 SAGENT PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075959 TEVA PHARMS USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076330 WEST-WARD PHARMS INT
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