Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212785
Company: SUN PHARM INDS INC

Products on ANDA 212785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDIUM IN-111 PENTETREOTIDE KIT	INDIUM IN-111 PENTETREOTIDE KIT	3mCi/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212785

INDIUM IN-111 PENTETREOTIDE KIT

INJECTABLE;INJECTION; 3mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDIUM IN-111 PENTETREOTIDE KIT	INDIUM IN-111 PENTETREOTIDE KIT	3mCi/ML	INJECTABLE;INJECTION	Prescription	No	AP	212785	SUN PHARM INDS INC
OCTREOSCAN	INDIUM IN-111 PENTETREOTIDE KIT	3mCi/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020314	CURIUM