FDA NDA · NDA019617

PREPIDIL

dinoprostone

Sponsor: PFIZER

APPLICATION

NDA019617

TYPE

NDA

ORIGINAL APPROVAL

1992-12-09

LATEST ACTION

2017-07-05

ROUTE

VAGINAL, ENDOCERVICAL

DOSAGE FORM

GEL

MARKETING STATUS

Prescription

Products

PREPIDIL · ReferencePrescription

DINOPROSTONE 0.5MG/3GM · GEL · ENDOCERVICAL

2017-07-05Labeling · Supplement 17 · standard — Label ↗AP

2015-02-03Manufacturing (CMC) · Supplement 18 · standardAP

2013-09-10Manufacturing (CMC) · Supplement 16 · standardAP

2010-02-12Labeling · Supplement 10 · standard — Label ↗AP

2002-04-26Manufacturing (CMC) · Supplement 4 · standardAP

2001-06-07Manufacturing (CMC) · Supplement 3 · standardAP

1999-08-13Labeling · Supplement 2 · standardAP

1996-02-27Labeling · Supplement 1 · standardAP

1992-12-09Type 3 - New Dosage Form · Original · standardAP

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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