Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076313
Company: WEST-WARD PHARMS INT
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 Yes
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription AP No Yes
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/28/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076313ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2018 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/27/2018 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/02/2013 SUPPL-8 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

03/03/2009 SUPPL-3 Labeling

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 INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 TEVA PHARMS USA
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 0.5MG 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 204669 HERITAGE PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 TEVA PHARMS USA
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

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 204669 HERITAGE PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 TEVA PHARMS USA
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

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