An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018124
Company: SUN PHARM INDS INC

Products on NDA 018124

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018124

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/1979	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-32	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
05/17/2016	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
05/26/2015	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/21/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/18/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/19/2005	SUPPL-13	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018124s013ltr.pdf
05/27/1997	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/1989	SUPPL-11	Labeling		Label is not available on this site.
04/02/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/27/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/02/1985	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/29/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/27/1984	SUPPL-3	Labeling		Label is not available on this site.
03/27/1984	SUPPL-2	Labeling		Label is not available on this site.
08/18/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018124

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017972s017,018124s032,019039s022lbl.pdf
04/19/2005	SUPPL-13	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf

Therapeutic Equivalents for NDA 018124

CIS-MDP

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIS-MDP	TECHNETIUM TC-99M MEDRONATE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	018124	SUN PHARM INDS INC
TECHNETIUM TC-99M MEDRONATE KIT	TECHNETIUM TC-99M MEDRONATE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	018107	CARDINAL HEALTH 414

Top