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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062129
Company: FOUGERA PHARMS

Products on ANDA 062129

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 062129

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/1979	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
02/03/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/08/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/19/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/05/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062129

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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