Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062474
Company: HERITAGE

Products on ANDA 062474

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 062474

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1983	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
11/01/2012	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/11/1997	SUPPL-9	Labeling		Label is not available on this site.
12/15/1993	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/15/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/29/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062474

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
NYSTATIN	NYSTATIN	500,000 UNITS	TABLET;ORAL	Prescription	No	AA	062506	TEVA