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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079198
Company: MYLAN INSTITUTIONAL

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
02/10/2011 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
02/21/2023 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
02/21/2023 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
02/21/2023 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/05/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
07/07/2017 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
07/07/2017 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
05/23/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
12/02/2011 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
07/14/2011 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

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
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