An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 220367
Company: STERANCO HLTHCARE

Products on ANDA 220367

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220367

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220367

NYSTATIN

SUSPENSION;ORAL; 100,000 UNITS/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062517	FOUGERA PHARMS INC
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	065148	GENUS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	203621	PHARM ASSOC
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062512	PHARMOBEDIENT
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	062832	SCIEGEN PHARMS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	214346	SENORES PHARMS
NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION;ORAL	Prescription	No	AA	220367	STERANCO HLTHCARE

Top