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.
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
| Physiological Effect | Decreased Embryonic Implantation Decreased Sperm Motility Inhibit Ovum Fertilization |
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: | RX | Dosage: | INTRAUTERINE DEVICE;INTRAUTERINE | Strength | 309MG/COPPER | ||||
| Approval Date: | Nov 15, 1984 | TE: | RLD: | Yes | |||||
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