Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075959
Company: TEVA PHARMS 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
11/21/2005 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
11/04/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

06/27/2017 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

07/12/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/12/2012 SUPPL-12 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 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
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

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 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
SANDOSTATIN OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

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