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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210850
Company: MAIA PHARMS INC

Products on NDA 210850

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SINCALIDE	SINCALIDE	0.005MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210850

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210850s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210850Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/210850Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210850s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210850Orig1s004ltr.pdf

Labels for NDA 210850

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210850s004lbl.pdf
11/22/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210850s000lbl.pdf

Therapeutic Equivalents for NDA 210850

SINCALIDE

POWDER;INTRAVENOUS; 0.005MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KINEVAC	SINCALIDE	0.005MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	017697	BRACCO
SINCALIDE	SINCALIDE	0.005MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	210850	MAIA PHARMS INC

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