Orange Book product · Brand (NDA)

PARAGARD T 380A

COPPER

Brand (NDA)NDA 018680RX COOPERSURGICAL

View COPPER family Open on FDA Orange Book

At a glance

Nov 15, 1984

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 15, 1984
42 yr 2 mo ago
Today
Exclusivity ends · D-193
New indication / change exclusivity (3 years)
Jun 28, 2027
in 1 yr

Pharmaceutical detail

Active ingredient

COPPER

Strength

309MG/COPPER

Dosage form

SYSTEM

Route

INTRAUTERINE

TE code

Not listed

Application

NDA 018680

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

D-193New indication / change exclusivity (3 years)
Jun 28, 2027
in 1 yr

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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