Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017874
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRANSDERM SCOP | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1979 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/01/2024 | SUPPL-51 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017874s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017874Orig1s051ltr.pdf | |
| 03/01/2019 | SUPPL-44 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017874Orig1s043, s044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874Orig1s044lbl.pdf | |
| 03/01/2019 | SUPPL-43 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017874Orig1s043, s044ltr.pdf | |
| 07/17/2017 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017874Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017874Orig1s042ltr.pdf | |
| 09/13/2017 | SUPPL-41 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/15/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017874s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017874Orig1s038ltr.pdf | |
| 01/10/2007 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017874s035_ltr.pdf |
| 03/22/2002 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17874s032ltr.pdf |
| 05/30/2000 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1996 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/2001 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018 & S027_SCOPOLAMINE_AP.pdf | |
| 05/31/1994 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1992 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1990 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/2001 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018 & S027_SCOPOLAMINE_AP.pdf | |
| 10/03/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1988 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/09/1981 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/10/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1980 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/01/2024 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017874s051lbl.pdf | |
| 03/01/2024 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017874s051lbl.pdf | |
| 03/01/2024 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017874s051lbl.pdf | |
| 03/01/2019 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf | |
| 03/01/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf | |
| 03/01/2019 | SUPPL-43 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf | |
| 07/17/2017 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017874Orig1s042lbl.pdf | |
| 04/30/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017874s038lbl.pdf | |
| 07/26/2001 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf | |
| 07/26/2001 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf |
TRANSDERM SCOP
SYSTEM;TRANSDERMAL; 1MG/72HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 208769 | ACTAVIS LABS UT INC |
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 203753 | MYLAN TECHNOLOGIES |
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 078830 | PADAGIS US |
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 212342 | RICONPHARMA LLC |
| TRANSDERM SCOP | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 017874 | BAXTER HLTHCARE CORP |