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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018107
Company: CARDINAL HEALTH 414

Products on NDA 018107

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/1981	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
11/13/2020	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018107Orig1s015ltr.pdf
09/10/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/21/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/26/2008	SUPPL-11	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018107s011ltr.pdf
11/23/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/21/1994	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/1992	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/24/1993	SUPPL-6	Labeling		Label is not available on this site.
09/30/1985	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/04/1997	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/24/1993	SUPPL-3	Labeling		Label is not available on this site.
04/12/1982	SUPPL-2	Labeling		Label is not available on this site.
04/13/1981	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 018107

TECHNETIUM TC-99M MEDRONATE KIT

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

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