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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018511
Company: JUBILANT

Products on NDA 018511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DRAXIMAGE DTPA	TECHNETIUM TC-99M PENTETATE KIT	N/A	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1989	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
06/07/2023	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018511Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018511Orig1s032ltr.pdf
10/12/2022	SUPPL-31	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018511Orig1s031ltr.pdf
12/26/2017	SUPPL-28	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018511Orig1s028ltr.pdf
01/05/2015	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
10/27/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/28/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/22/2017	SUPPL-20		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
09/23/2011	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018511s019ltr.pdf
12/10/2001	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/02/1999	SUPPL-6	Labeling		Label is not available on this site.
04/02/1999	SUPPL-5	Labeling		Label is not available on this site.
08/23/1996	SUPPL-4	Labeling		Label is not available on this site.
08/09/1994	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/07/1990	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018511

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2023	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018511Orig1s032lbl.pdf
10/12/2022	SUPPL-31	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf
10/12/2022	SUPPL-31	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf
10/12/2022	SUPPL-31	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf
10/12/2022	SUPPL-31	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018511Orig1s031lbl.pdf
12/26/2017	SUPPL-28	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf
12/22/2017	SUPPL-20	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
09/23/2011	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf

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