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FDA NDA · NDA020088
NORPLANT SYSTEM IN PLASTIC CONTAINER
Sponsor: WYETH PHARMS INC
APPLICATION
NDA020088
TYPE
NDA
ORIGINAL APPROVAL
1990-12-10
LATEST ACTION
2005-07-18
ROUTE
IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Discontinued
Products
NORPLANT SYSTEM IN PLASTIC CONTAINERDiscontinued
LEVONORGESTREL 36MG/IMPLANT · IMPLANT · IMPLANTATION
Approval history
2001-03-14Manufacturing (CMC) · Supplement 14 · priorityAP
1999-06-21Labeling · Supplement 12 · priorityAP
1999-03-30Manufacturing (CMC) · Supplement 11 · priorityAP
1997-07-08Manufacturing (CMC) · Supplement 8 · priorityAP
1997-01-14Manufacturing (CMC) · Supplement 7 · priorityAP
1996-06-03Labeling · Supplement 6 · priorityAP
1995-08-30Manufacturing (CMC) · Supplement 4 · priorityAP
1995-07-07Labeling · Supplement 5 · priorityAP
1994-07-11Labeling · Supplement 3 · priorityAP
1993-03-26Labeling · Supplement 1 · priorityAP
1990-12-10Type 3 - New Dosage Form · Original · priorityAP
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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