Details for New Drug Application (NDA): 062302

✉ Email this page to a colleague

NDA 062302 describes OTOBIOTIC, which is a drug marketed by Schering and is included in one NDA. Additional details are available on the OTOBIOTIC profile page.

The generic ingredient in OTOBIOTIC is hydrocortisone; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Additional details are available on the hydrocortisone; polymyxin b sulfate profile page.

Summary for 062302

Tradename:	OTOBIOTIC
Applicant:	Schering
Ingredient:	hydrocortisone; polymyxin b sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OTIC			Strength	5MG/ML;EQ 10,000 UNITS BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.