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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210828
Company: UIHC PET IMAGING

Products on NDA 210828

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALLIUM GA 68 EDOTREOTIDE	GALLIUM GA-68 EDOTREOTIDE	0.5-4mCi/ML	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210828

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210828s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210828Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210828Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210828s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210828Orig1s003ltr.pdf
12/22/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210828s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210828Orig1s002ltr.pdf

Labels for NDA 210828

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2023	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210828s003lbl.pdf
07/27/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210828s003lbl.pdf
12/22/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210828s002lbl.pdf
08/21/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210828s000lbl.pdf

Therapeutic Equivalents for NDA 210828

GALLIUM GA 68 EDOTREOTIDE

SOLUTION;INTRAVENOUS; 0.5-4mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GALLIUM GA 68 EDOTREOTIDE	GALLIUM GA-68 EDOTREOTIDE	0.5-4mCi/ML	SOLUTION;INTRAVENOUS	Prescription	No	AP	218845	METHODIST
GALLIUM GA 68 EDOTREOTIDE	GALLIUM GA-68 EDOTREOTIDE	0.5-4mCi/ML	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	210828	UIHC PET IMAGING

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