Norgesic, Norgesic Forte

NDA 13416, held by Bausch. Aspirin; Caffeine; Orphenadrine Citrate.

As of Nov 13, 2026, NDA 13416 (Norgesic, Norgesic Forte), held by Bausch, was first approved by FDA on Mar 4, 1964, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 4, 1964
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 4, 1964	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Norgesic385MG;30MG;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aspirin; Caffeine; Orphenadrine Citrate	DiscontinuedReference drug
Norgesic Forte770MG;60MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aspirin; Caffeine; Orphenadrine Citrate	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 25, 2002	Supplement 21Labeling	Approved	Letter
Mar 26, 1999	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 12, 1997	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 13, 1995	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 16, 1993	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 5, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 30, 1988	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 28, 1987	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 20Labeling	Approved	None posted
Jul 27, 1977	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 27, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 4, 1964	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 13416
Drugs@FDA: Overview at FDA
Company: Bausch Health

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters