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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063305
Company: SUN PHARMA CANADA

Products on ANDA 063305

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063305

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/1993	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
07/05/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/10/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/11/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/30/1996	SUPPL-5	Labeling		Label is not available on this site.
08/24/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/30/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/30/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/19/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 063305

NYSTATIN AND TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL; 100,000 UNITS/GM;0.1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	214186	ALEMBIC
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	207741	DR REDDYS
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	207217	EPIC PHARMA LLC
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	062602	FOUGERA PHARMS INC
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	214751	MACLEODS PHARMS LTD
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	207380	PADAGIS ISRAEL
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	206785	RISING
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	063305	SUN PHARMA CANADA
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	207764	ZYDUS LIFESCIENCES

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