← FDA DRUG APPROVALS

FDA NDA · NDA017398

REGONOL

pyridostigmine bromide

Sponsor: SANDOZ

APPLICATION
NDA017398
TYPE
NDA
ORIGINAL APPROVAL
1973-08-14
LATEST ACTION
2021-04-05
ROUTE
INTRAVENOUS, PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

REGONOLPrescription
PYRIDOSTIGMINE BROMIDE 5MG/ML · INJECTABLE · INJECTION

Approval history

2021-04-05Labeling · Supplement 25 · standard — Letter ↗AP
2016-05-18Manufacturing (CMC) · Supplement 21 · standardAP
2013-07-22Manufacturing (CMC) · Supplement 18 · standardAP
2004-09-21Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2003-10-17Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
1999-07-12Labeling · Supplement 13 · standardAP
1999-03-15Manufacturing (CMC) · Supplement 12 · standardAP
1999-03-05Labeling · Supplement 5AP
1997-03-04Manufacturing (CMC) · Supplement 11 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 10 · standardAP
1992-10-06Manufacturing (CMC) · Supplement 9 · standardAP
1990-10-05Manufacturing (CMC) · Supplement 8 · standardAP
1988-03-30Manufacturing (CMC) · Supplement 7 · standardAP
1987-02-10Manufacturing (CMC) · Supplement 6 · standardAP
1982-05-18Labeling · Supplement 4AP
1982-05-18Manufacturing (CMC) · Supplement 3 · standardAP
1980-11-13Labeling · Supplement 2AP
1980-11-13Manufacturing (CMC) · Supplement 1 · standardAP
1973-08-14Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →