Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213566
Company: MACLEODS PHARMS LTD

Products on ANDA 213566

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213566

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213566

NYSTATIN

CREAM;TOPICAL; 100,000 UNITS/GM
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	062949	ACTAVIS MID ATLANTIC
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	219527	AUROBINDO PHARMA
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	061966	COSETTE PHARMS NC
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	207733	CROWN LABS INC
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	062129	FOUGERA PHARMS
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	213566	MACLEODS PHARMS LTD
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	062225	PADAGIS US
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	064022	SUN PHARMA CANADA
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	212557	TORRENT