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Drugs@FDA: FDA-Approved Drugs

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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
05/22/2025	SUPPL-43	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018035s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018035Orig1s043ltr.pdf
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
05/22/2025	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018035s043lbl.pdf
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

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