Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062876
Company: TARO

Products on ANDA 062876

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062876

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/29/1988	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
07/23/2007	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/04/1996	SUPPL-10	Labeling		Label is not available on this site.
07/10/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/30/1989	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/10/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062876

NYSTATIN

SUSPENSION;ORAL; 100,000 UNITS/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062517	FOUGERA PHARMS INC
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	065148	GENUS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	214346	LEADING
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062832	MLV
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	203621	PHARM ASSOC
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062876	TARO
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062512	WOCKHARDT BIO AG