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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020119
Company: HQ SPECLT PHARMA

Products on NDA 020119

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VUMON	TENIPOSIDE	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/1992	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020119s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020119Orig1s013ltr.pdf
02/26/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/20/2011	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010,s011ltr.pdf
10/20/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010s011ltr.pdf
02/10/2009	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020119s009ltr.pdf
01/28/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/17/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/05/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/01/2002	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20119slr004ltr.pdf
03/03/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/28/1992	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020119

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020119s013lbl.pdf
10/20/2011	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf
10/20/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf

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