Details for New Drug Application (NDA): 085100

✉ Email this page to a colleague

NDA 085100 describes DOLENE AP-65, which is a drug marketed by Lederle and is included in one NDA. Additional details are available on the DOLENE AP-65 profile page.

The generic ingredient in DOLENE AP-65 is acetaminophen; propoxyphene hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene hydrochloride profile page.

Summary for 085100

Tradename:	DOLENE AP-65
Applicant:	Lederle
Ingredient:	acetaminophen; propoxyphene hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	650MG;65MG
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.