Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006403
Company: NOVARTIS

Products on NDA 006403

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRISCOLINE	TOLAZOLINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/1948	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2002	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/29/1999	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/28/1998	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/16/1998	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/27/1995	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
12/08/1994	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/29/1991	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
01/31/1990	SUPPL-14	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/10/1987	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/07/1986	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1987	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/22/1985	SUPPL-8	Efficacy		Label is not available on this site.