← FDA DRUG APPROVALS

FDA NDA · NDA019268

CYTOTEC

misoprostol

Sponsor: PFIZER

APPLICATION
NDA019268
TYPE
NDA
ORIGINAL APPROVAL
1988-12-27
LATEST ACTION
2018-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CYTOTEC · ReferencePrescription
MISOPROSTOL 0.1MG · TABLET · ORAL
CYTOTEC · ReferencePrescription
MISOPROSTOL 0.2MG · TABLET · ORAL

Approval history

2018-02-28Labeling · Supplement 51 · standard — Label ↗AP
2016-12-19Labeling · Supplement 49 · standard — Label ↗AP
2013-02-08Manufacturing (CMC) · Supplement 48 · priorityAP
2012-11-19Labeling · Supplement 47 · standard — Label ↗AP
2009-09-11Labeling · Supplement 41 · standard — Letter ↗AP
2003-08-13Labeling · Supplement 40 · standard — Letter ↗AP
2003-08-13Labeling · Supplement 39 · standard — Letter ↗AP
2002-07-01Manufacturing (CMC) · Supplement 38 · priorityAP
2002-04-17Labeling · Supplement 37 · standard — Label ↗AP
2000-10-19Manufacturing (CMC) · Supplement 35 · priorityAP
2000-10-19Manufacturing (CMC) · Supplement 36 · priorityAP
2000-06-22Labeling · Supplement 31 · standardAP
2000-01-07Manufacturing (CMC) · Supplement 33 · priorityAP
1999-08-11Manufacturing (CMC) · Supplement 32 · priorityAP
1998-12-03Manufacturing (CMC) · Supplement 30 · priorityAP
1998-10-15Manufacturing (CMC) · Supplement 29 · priorityAP
1998-10-15Manufacturing (CMC) · Supplement 28 · priorityAP
1998-07-14Manufacturing (CMC) · Supplement 27 · priorityAP
1997-08-13Labeling · Supplement 23 · standardAP
1997-07-30Manufacturing (CMC) · Supplement 26 · priorityAP
1997-04-10Manufacturing (CMC) · Supplement 25 · priorityAP
1996-06-11Manufacturing (CMC) · Supplement 22 · priorityAP
1996-06-10Manufacturing (CMC) · Supplement 24 · priorityAP
1994-05-31Manufacturing (CMC) · Supplement 18 · priorityAP
1993-05-10Manufacturing (CMC) · Supplement 17 · priorityAP
1992-10-28Manufacturing (CMC) · Supplement 16 · priorityAP
1991-07-29Labeling · Supplement 15AP
1991-06-21Manufacturing (CMC) · Supplement 9 · priorityAP
1991-04-23Labeling · Supplement 14AP
1990-09-21Manufacturing (CMC) · Supplement 12 · priorityAP
1990-09-06Labeling · Supplement 13AP
1990-07-16Manufacturing (CMC) · Supplement 6 · priorityAP
1990-05-09Manufacturing (CMC) · Supplement 7 · priorityAP
1990-04-05Labeling · Supplement 10AP
1990-04-05Labeling · Supplement 8AP
1989-06-27Manufacturing (CMC) · Supplement 4 · priorityAP
1989-04-18Manufacturing (CMC) · Supplement 2 · priorityAP
1989-02-08Manufacturing (CMC) · Supplement 1 · priorityAP
1988-12-27Type 1 - New Molecular Entity · Original · priority — Review ↗AP
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 →