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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208205
Company: LUPIN LTD

Products on ANDA 208205

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208205

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208205

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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