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Generated: October 22, 2018

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Details for New Drug Application (NDA): 018680

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NDA 018680 describes PARAGARD T 380A, which is a drug marketed by Coopersurgical and is included in one NDA. It is available from two suppliers. Additional details are available on the PARAGARD T 380A profile page.

The generic ingredient in PARAGARD T 380A is copper. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.
Summary for 018680
Tradename:PARAGARD T 380A
Applicant:Coopersurgical
Ingredient:copper
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018680
Medical Subject Heading (MeSH) Categories for 018680
Suppliers and Packaging for NDA: 018680
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARAGARD T 380A copper INTRAUTERINE DEVICE;INTRAUTERINE 018680 NDA Teva Women's Health, Inc. 51285-204 51285-204-01 1 POUCH in 1 PACKAGE (51285-204-01) > 1 INTRAUTERINE DEVICE in 1 POUCH
PARAGARD T 380A copper INTRAUTERINE DEVICE;INTRAUTERINE 018680 NDA CooperSurgical, Inc. 59365-5128 59365-5128-1 1 POUCH in 1 CARTON (59365-5128-1) > 1 INTRAUTERINE DEVICE in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength309MG/COPPER
Approval Date:Nov 15, 1984TE:RLD:Yes

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