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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019039
Company: SUN PHARM INDS INC

Products on NDA 019039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIS-PYRO	TECHNETIUM TC-99M PYROPHOSPHATE KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1987	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017972s017,018124s032,019039s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017972Orig1s017,018124Orig1s032,019039Orig1s022ltr.pdf
11/24/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/12/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/27/2002	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19039s002ltr.pdf
05/27/1997	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019039

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017972s017,018124s032,019039s022lbl.pdf

Therapeutic Equivalents for NDA 019039

CIS-PYRO

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIS-PYRO	TECHNETIUM TC-99M PYROPHOSPHATE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	019039	SUN PHARM INDS INC
TECHNESCAN PYP KIT	TECHNETIUM TC-99M PYROPHOSPHATE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	017538	CURIUM

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