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FDA NDA · NDA011483

SYNALGOS-DC

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
NDA011483
TYPE
NDA
ORIGINAL APPROVAL
1958-07-07
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SYNALGOS-DC · ReferenceDiscontinued
ASPIRIN 356.4MG, CAFFEINE 30MG, DIHYDROCODEINE BITARTRATE 16MG · CAPSULE · ORAL

Approval history

2026-06-18REMS · Supplement 39 — Letter ↗AP
2025-12-22Labeling · Supplement 38 · standard — Letter ↗AP
2024-11-21Labeling · Supplement 37 · standard — Label ↗AP
2024-10-31REMS · Supplement 36 — Letter ↗AP
2023-12-15Labeling · Supplement 35 · standard — Label ↗AP
2021-04-28Labeling · Supplement 34 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 33 · standard — Label ↗AP
2018-09-18REMS · Supplement 31 — Letter ↗AP
2018-09-18Labeling · Supplement 32 · standard — Letter ↗AP
2017-08-29Labeling · Supplement 30 · standard — Label ↗AP
2016-12-16Labeling · Supplement 29 · standard — Letter ↗AP
2013-05-09Labeling · Supplement 27 · standard — Letter ↗AP
2006-05-11Manufacturing (CMC) · Supplement 23AP
2006-03-13Manufacturing (CMC) · Supplement 22AP
2001-10-31Labeling · Supplement 15 · standardAP
1987-08-05Manufacturing (CMC) · Supplement 14 · standardAP
1987-02-03Manufacturing (CMC) · Supplement 13 · standardAP
1983-09-06Labeling · Supplement 11AP
1983-09-06Manufacturing (CMC) · Supplement 12 · standardAP
1958-07-07Type 4 - New Combination · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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