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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062364
Company: TARO

Products on ANDA 062364

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%	CREAM;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1987	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
09/04/2007	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
03/19/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/27/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/24/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/30/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/03/1993	SUPPL-6	Labeling		Label is not available on this site.
03/16/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/19/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/30/1992	SUPPL-3	Labeling		Label is not available on this site.
12/07/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/12/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062364

NYSTATIN AND TRIAMCINOLONE ACETONIDE

CREAM;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%	CREAM;TOPICAL	Prescription	No	AT	214090	ALEMBIC
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	209990	AMNEAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	207730	CROWN LABS INC
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	208326	DR REDDYS
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	062599	FOUGERA PHARMS INC
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	208136	GLENMARK PHARMS LTD
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	208205	LUPIN LTD
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	214181	MACLEODS PHARMS LTD
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	208479	PADAGIS ISRAEL
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Prescription	No	AT	062364	TARO

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