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 one supplier. 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. One supplier is 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. One supplier is 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 018680
Generic Entry Date for 018680*:
Constraining patent/regulatory exclusivity:
NEW INSERTER INTENDED TO FACILITATE SINGLE-HAND PLACEMENT Dosage:
SYSTEM;INTRAUTERINE |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | SYSTEM;INTRAUTERINE | 018680 | NDA | CooperSurgical, Inc. | 59365-5128 | 59365-5128-1 | 1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH |
| PARAGARD T 380A | copper | SYSTEM;INTRAUTERINE | 018680 | NDA | CooperSurgical, Inc. | 59365-5129 | 59365-5129-1 | 1 POUCH in 1 CARTON (59365-5129-1) / 1 INTRAUTERINE DEVICE in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;INTRAUTERINE | Strength | 309MG/COPPER | ||||
| Approval Date: | Nov 15, 1984 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 28, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW INSERTER INTENDED TO FACILITATE SINGLE-HAND PLACEMENT | ||||||||
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