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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062225
Company: PADAGIS US

Products on ANDA 062225

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 062225

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/1979	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
12/03/2009	SUPPL-11	Labeling		Label is not available on this site.
04/17/2009	SUPPL-10	Labeling		Label is not available on this site.
09/05/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/15/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/04/1993	SUPPL-5	Labeling		Label is not available on this site.
07/06/1994	SUPPL-4	Labeling		Label is not available on this site.
03/18/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062225

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	061966	COSETTE
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	TARO
NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM;TOPICAL	Prescription	No	AT	212557	TORRENT

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