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FDA NDA · NDA020756

CRINONE

Sponsor: WATSON LABS INC

APPLICATION
NDA020756
TYPE
NDA
ORIGINAL APPROVAL
1997-05-13
LATEST ACTION
2003-09-17
ROUTE
VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

CRINONE · ReferencePrescription
PROGESTERONE 8% · GEL · VAGINAL

Approval history

2003-09-17Labeling · Supplement 12 · standard — Letter ↗AP
2001-04-20Manufacturing (CMC) · Supplement 10 · priority — Letter ↗AP
2001-04-03Labeling · Supplement 9 · standard — Letter ↗AP
1998-12-16Manufacturing (CMC) · Supplement 7 · priorityAP
1998-05-11Labeling · Supplement 6 · standardAP
1998-02-17Manufacturing (CMC) · Supplement 2 · priorityAP
1997-12-22Manufacturing (CMC) · Supplement 1 · priorityAP
1997-12-11Manufacturing (CMC) · Supplement 5 · priorityAP
1997-05-13Type 3 - New Dosage Form · 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.

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