← FDA DRUG APPROVALS

FDA NDA · NDA018680

PARAGARD T 380A

copper

Sponsor: COOPERSURGICAL

APPLICATION
NDA018680
TYPE
NDA
ORIGINAL APPROVAL
1984-11-15
LATEST ACTION
2024-06-28
ROUTE
INTRAUTERINE
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

PARAGARD T 380A · ReferencePrescription
COPPER 309MG/COPPER · SYSTEM · INTRAUTERINE

Approval history

2024-06-28Efficacy · Supplement 74 · standard — Label ↗AP
2019-09-05Labeling · Supplement 70 · standard — Letter ↗AP
2019-09-05Labeling · Supplement 69 · standard — Letter ↗AP
2014-02-20Manufacturing (CMC) · Supplement 68 · standardAP
2013-06-11Labeling · Supplement 66 · unknown — Letter ↗AP
2005-09-01Efficacy · Supplement 60 · unknown — Label ↗AP
2003-04-22Labeling · Supplement 57 · standard — Letter ↗AP
2001-09-27Manufacturing (CMC) · Supplement 56 · standardAP
2001-08-24Labeling · Supplement 55 · standard — Label ↗AP
2000-09-20Manufacturing (CMC) · Supplement 54 · standardAP
2000-04-25Manufacturing (CMC) · Supplement 53 · standardAP
2000-03-27Manufacturing (CMC) · Supplement 52 · standardAP
1999-12-14Manufacturing (CMC) · Supplement 51 · standardAP
1999-07-23Manufacturing (CMC) · Supplement 50 · standardAP
1999-07-23Manufacturing (CMC) · Supplement 49 · standardAP
1999-02-02Manufacturing (CMC) · Supplement 47 · standardAP
1999-02-02Manufacturing (CMC) · Supplement 48 · standardAP
1998-07-07Manufacturing (CMC) · Supplement 43 · standardAP
1998-07-07Manufacturing (CMC) · Supplement 44 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 45 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 46 · standardAP
1998-02-10Manufacturing (CMC) · Supplement 42 · standardAP
1997-11-03Manufacturing (CMC) · Supplement 41 · standardAP
1997-10-09Manufacturing (CMC) · Supplement 40 · standardAP
1997-06-04Manufacturing (CMC) · Supplement 39 · standardAP
1997-03-13Manufacturing (CMC) · Supplement 38 · standardAP
1997-02-14Manufacturing (CMC) · Supplement 37 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 36 · standardAP
1996-04-12Manufacturing (CMC) · Supplement 35 · standardAP
1996-04-12Manufacturing (CMC) · Supplement 34 · standardAP
1996-01-24Manufacturing (CMC) · Supplement 32 · standardAP
1996-01-18Manufacturing (CMC) · Supplement 33 · standardAP
1995-07-24Labeling · Supplement 31 · standardAP
1995-07-24Manufacturing (CMC) · Supplement 30 · standardAP
1994-05-19Efficacy · Supplement 26 · standardAP
1993-06-17Manufacturing (CMC) · Supplement 25 · standardAP
1991-11-25Manufacturing (CMC) · Supplement 19 · standardAP
1991-11-25Labeling · Supplement 23AP
1991-11-25Manufacturing (CMC) · Supplement 14 · standardAP
1991-11-25Manufacturing (CMC) · Supplement 20 · standardAP
VIEW ON DRUGS@FDA ↗

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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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