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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019645
Company: ROCHE PALO

Medication Guide

Products on NDA 019645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TORADOL	KETOROLAC TROMETHAMINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1991	ORIG-1	Approval	Type 3 - New Dosage Form	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
03/26/2013	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019645Orig1s019ltr.pdf
12/16/2008	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019645s018ltr.pdf
11/13/2007	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s017ltr.pdf
01/19/2007	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s016ltr.pdf
10/11/2001	SUPPL-9	Labeling		Label is not available on this site.
10/11/2001	SUPPL-8	Labeling		Label is not available on this site.
10/11/2001	SUPPL-7	Labeling		Label is not available on this site.
10/11/2001	SUPPL-6	Labeling		Label is not available on this site.
10/11/2001	SUPPL-5	Labeling		Label is not available on this site.
12/07/1994	SUPPL-4	Labeling		Label is not available on this site.
10/11/2001	SUPPL-3	Labeling		Label is not available on this site.
09/18/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019645

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2013	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf
11/13/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf
01/19/2007	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf

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