Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062349
Company: G AND W LABS INC

Products on ANDA 062349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/1982	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
10/17/2001	SUPPL-31	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/16/1998	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/03/1997	SUPPL-28	Labeling		Label is not available on this site.
05/08/1997	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
04/15/1994	SUPPL-26	Labeling		Label is not available on this site.
01/14/1994	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
07/08/1993	SUPPL-24	Labeling		Label is not available on this site.
11/09/1992	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/16/1992	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/11/1991	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/11/1990	SUPPL-18	Labeling		Label is not available on this site.
07/24/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/07/1989	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/26/1989	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.