Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018680
Company: COOPERSURGICAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARAGARD T 380A COPPER 309MG/COPPER INTRAUTERINE DEVICE;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
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
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

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