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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061966
Company: COSETTE PHARMS NC

Products on ANDA 061966

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 061966

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/1976	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
08/30/2001	SUPPL-25	Manufacturing (CMC)-Facility		Label is not available on this site.
06/13/1996	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/21/1993	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/21/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/21/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/21/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/27/1993	SUPPL-11	Labeling		Label is not available on this site.
08/09/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/25/1992	SUPPL-9	Labeling		Label is not available on this site.
11/10/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 061966

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

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