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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216839
Company: GLAND PHARMA LTD

Products on ANDA 216839

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 0.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 0.1MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216839

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216839

OCTREOTIDE ACETATE

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

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 (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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