Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218273
Company: COSETTE PHARMS NC

Products on ANDA 218273

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218273

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218273Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 218273

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE

SUSPENSION/DROPS;OTIC; EQ 0.2% BASE;1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	Yes	AB	020805	SANDOZ
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	218273	COSETTE PHARMS NC