Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062517
Company: FOUGERA PHARMS INC

Products on ANDA 062517

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 062517

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/1984	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
12/14/2004	SUPPL-9	Labeling		Label is not available on this site.
12/13/2004	SUPPL-6	Labeling		Label is not available on this site.
01/26/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/11/1998	SUPPL-4	Labeling		Label is not available on this site.
06/23/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/27/1993	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062517

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