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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077450
Company: FRESENIUS KABI USA

Products on ANDA 077450

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077450

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
06/30/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 077450

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	216807	GLAND PHARMA LTD
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	075959	MEITHEAL
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	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	216807	GLAND PHARMA LTD
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	075959	MEITHEAL
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	076330	WEST-WARD PHARMS INT

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