Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017874
Company: GLAXOSMITHKLINE CON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANSDERM SCOP SCOPOLAMINE 1MG/72HR FILM, EXTENDED RELEASE;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
03/01/2019 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
03/01/2019 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

FILM, EXTENDED RELEASE;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 FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 203753 MYLAN TECHNOLOGIES
SCOPOLAMINE SCOPOLAMINE 1MG/72HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 078830 PERRIGO PHARMS CO
TRANSDERM SCOP SCOPOLAMINE 1MG/72HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 017874 GLAXOSMITHKLINE CON

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