Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214186
Company: ALEMBIC

Products on ANDA 214186

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214186

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	208300	GLENMARK PHARMS LTD
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	210077	STRIDES PHARMA
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	063305	TARO
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT;TOPICAL	Prescription	No	AT	207764	ZYDUS LIFESCIENCES