Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062472
Company: PADAGIS US

Products on ANDA 062472

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/1984	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
04/17/2009	SUPPL-4	Labeling		Label is not available on this site.
09/05/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/06/1994	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062472

NYSTATIN

OINTMENT;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	OINTMENT;TOPICAL	Prescription	No	AT	062840	ACTAVIS MID ATLANTIC
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	209114	COSETTE
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	062124	FOUGERA PHARMS
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	209082	LYNE
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	213826	MACLEODS PHARMS LTD
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	062472	PADAGIS US
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	211838	TORRENT
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	207767	ZYDUS LIFESCIENCES