Drugs@FDA: FDA-Approved Drugs
Company: COOPERSURGICAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PARAGARD T 380A | COPPER | 309MG/COPPER | SYSTEM;INTRAUTERINE | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/15/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018680_original_approval.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/28/2024 | SUPPL-74 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018680Orig1s074lbl.pdf | |
| 09/05/2019 | SUPPL-70 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018680s069s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/18680Orig1s069,%2018680Orig1s070ltr.pdf | |
| 09/05/2019 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018680s069s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/18680Orig1s069, 18680Orig1s070ltr.pdf | |
| 02/20/2014 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/2013 | SUPPL-66 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018680s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018680Orig1s066ltr.pdf | |
| 09/01/2005 | SUPPL-60 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018680s060ltr.pdf | |
| 04/22/2003 | SUPPL-57 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18680slr057ltr.pdf |
| 09/27/2001 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2001 | SUPPL-55 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18680s55lbl.pdf | |
| 09/20/2000 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/2000 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1998 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1998 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1998 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1997 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1997 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1997 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1997 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1996 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/24/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/24/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-26 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 06/17/1993 | SUPPL-25 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/20/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1991 | SUPPL-16 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 05/03/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1991 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/01/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/17/1989 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 10/17/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/18/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/28/2024 | SUPPL-74 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018680Orig1s074lbl.pdf | |
| 09/05/2019 | SUPPL-70 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018680s069s070lbl.pdf | |
| 09/05/2019 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018680s069s070lbl.pdf | |
| 06/11/2013 | SUPPL-66 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018680s066lbl.pdf | |
| 09/01/2005 | SUPPL-60 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf | |
| 08/24/2001 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18680s55lbl.pdf |