Synalgos-Dc

NDA 11483, held by Sun Pharm Industries. Aspirin; Caffeine; Dihydrocodeine Bitartrate.

As of Nov 14, 2026, NDA 11483 (Synalgos-Dc), held by Sun Pharm Industries, was first approved by FDA on Jul 7, 1958, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 7, 1958
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 7, 1958	Original applicationNew combination · Standard review	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Synalgos-Dc356.4MG;30MG;16MG · capsule;oral	Aspirin; Caffeine; Dihydrocodeine Bitartrate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 39REMS	Approved	Letter
Dec 22, 2025	Supplement 38Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 21, 2024	Supplement 37Labeling · Standard review	Approved	Label
Oct 31, 2024	Supplement 36REMS	Approved	Letter
Dec 15, 2023	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 28, 2021	Supplement 34Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 33Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 31REMS	Approved	Label Letter
Sep 18, 2018	Supplement 32Labeling · Standard review	Approved	Label Letter
Aug 29, 2017	Supplement 30Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 29Labeling · Standard review	Approved	Label Letter
May 9, 2013	Supplement 27Labeling · Standard review	Approved	Label Letter
May 11, 2006	Supplement 23Manufacturing	Approved	None posted
Mar 13, 2006	Supplement 22Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Aug 5, 1987	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 3, 1987	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 6, 1983	Supplement 11Labeling	Approved	None posted
Sep 6, 1983	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 7, 1958	Original applicationNew combination · Standard review	Approved	REMS

Identifiers

Application: NDA 11483
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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