Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062838
Company: SUN PHARM INDUSTRIES

Products on ANDA 062838

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062838

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1988	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
06/28/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
10/30/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
12/05/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/30/1998	SUPPL-5	Labeling		Label is not available on this site.
02/24/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/22/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/15/1994	SUPPL-2	Labeling		Label is not available on this site.
01/12/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062838

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