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): 018035
Company: JUBILANT

Products on NDA 018035

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DRAXIMAGE MDP-10	TECHNETIUM TC-99M MEDRONATE	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No
DRAXIMAGE MDP-25	TECHNETIUM TC-99M MEDRONATE	N/A	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018035

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/1978	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-035_Technescan%20MDP.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2011	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018035s032ltr.pdf
10/22/2010	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018035s029ltr.pdf
07/08/2009	SUPPL-24	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018035s024ltr.pdf
02/27/2004	SUPPL-18	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18035scr018ltr.pdf
07/03/2002	SUPPL-17	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18035scm017ltr.pdf
04/02/1999	SUPPL-16	Labeling		Label is not available on this site.
04/02/1999	SUPPL-15	Labeling		Label is not available on this site.
08/23/1996	SUPPL-14	Labeling		Label is not available on this site.
12/30/1994	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/1988	SUPPL-12	Labeling		Label is not available on this site.
12/08/1988	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1979	SUPPL-4	Labeling		Label is not available on this site.
04/26/1979	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/29/1980	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/30/1980	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018035

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2011	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf
10/22/2010	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf
07/08/2009	SUPPL-24	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf

Top