Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050299
Company: CHARTWELL MOLECULES

Products on NDA 050299

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NILSTAT	NYSTATIN	100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050299

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/1971	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/1999	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
05/18/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/28/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/28/1995	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
02/16/1995	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
09/01/1982	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1980	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/1978	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/1978	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
01/11/1977	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/23/1974	SUPPL-11	Manufacturing (CMC)-Formulation		Label is not available on this site.
07/22/1974	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
02/15/1974	SUPPL-9	Labeling		Label is not available on this site.
02/11/1974	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1974	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/17/1972	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/28/1972	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
07/25/1984	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/02/1984	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/14/1983	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/13/1983	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.