Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208838
Company: LYNE

Products on ANDA 208838

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208838

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208838Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 208838

NYSTATIN

POWDER;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	POWDER;TOPICAL	Prescription	No	AT	065175	ADRASTEA PHARMA
NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	065203	DR REDDYS LABS SA
NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	210532	EPIC PHARMA LLC
NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	065138	LUPIN
NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	208838	LYNE
NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	065183	UPSHER SMITH LABS
NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	208581	ZYDUS PHARMS
NYSTOP	NYSTATIN	100,000 UNITS/GM	POWDER;TOPICAL	Prescription	No	AT	064118	PADAGIS US