Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062506
Company: TEVA

Products on ANDA 062506

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN	NYSTATIN	500,000 UNITS	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062506

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/1984	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
08/30/2001	SUPPL-39	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-38	Manufacturing (CMC)-Facility		Label is not available on this site.
12/21/1999	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/1998	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
08/19/1997	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
06/05/1997	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
04/02/1997	SUPPL-33	Labeling		Label is not available on this site.
11/26/1996	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
10/04/1996	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
01/07/1997	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
08/16/1996	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
01/25/1996	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
01/25/1996	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/25/1996	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
02/10/1995	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/02/1995	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/09/1994	SUPPL-23	Labeling		Label is not available on this site.
01/14/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-15	Labeling		Label is not available on this site.
12/03/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062506

NYSTATIN

TABLET;ORAL; 500,000 UNITS
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NYSTATIN	NYSTATIN	500,000 UNITS	TABLET;ORAL	Prescription	No	AA	062474	HERITAGE PHARMS
NYSTATIN	NYSTATIN	500,000 UNITS	TABLET;ORAL	Prescription	No	AA	062838	SUN PHARM INDUSTRIES
NYSTATIN	NYSTATIN	500,000 UNITS	TABLET;ORAL	Prescription	No	AA	062506	TEVA