Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213826
Company: MACLEODS PHARMS LTD

Products on ANDA 213826

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213826

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213826

NYSTATIN

OINTMENT;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	OINTMENT;TOPICAL	Prescription	No	AT	062840	ACTAVIS MID ATLANTIC
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	209114	COSETTE
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	062124	FOUGERA PHARMS
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	209082	LYNE
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	213826	MACLEODS PHARMS LTD
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	062472	PADAGIS US
NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT;TOPICAL	Prescription	No	AT	207767	ZYDUS LIFESCIENCES