Application 018680
- Type
- NDA
- Sponsor
- COOPERSURGICAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PARAGARD T 380A | COPPER | INTRAUTERINE DEVICE;INTRAUTERINE | 309MG/COPPER | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51285-204 | ParaGard T 380A | Copper | Teva Women's Health, Inc. | NDA | Current |
| 51285-204 | ParaGard T 380A | Copper | Teva Women's Health, Inc. | NDA | Current |
| 59365-5128 | ParaGard T 380A | Copper | CooperSurgical, Inc. | NDA | Current |
| 59365-5128 | ParaGard T 380A | Copper | CooperSurgical, Inc. | NDA | Current |
| 59365-5128 | ParaGard T 380A | Copper | CooperSurgical, Inc. | NDA | Current |
| 59365-5128 | ParaGard T 380A | Copper | CooperSurgical, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78948 | SUPPL | 2024-09-16 |
| 82760 | SUPPL | 2024-07-01 |
| 59935 | SUPPL | 2019-09-11 |
| 59934 | SUPPL | 2019-09-11 |
| 59930 | SUPPL | 2019-09-06 |
| 59928 | SUPPL | 2019-09-06 |
| 33555 | SUPPL | 2013-06-18 |
| 1020 | SUPPL | 2013-06-13 |
| 20148 | ORIG | 2011-02-15 |
| 15088 | SUPPL | 2005-09-08 |
| 11275 | SUPPL | 2005-09-08 |
| 1019 | SUPPL | 2003-05-29 |
| 33554 | SUPPL | 2003-04-30 |