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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017744
Company: SEBELA IRELAND LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOTOFEN ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE 0.025MG;1MG TABLET;ORAL Prescription None Yes Yes
MOTOFEN HALF-STRENGTH ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE 0.025MG;0.5MG TABLET;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/14/1978 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination 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
03/28/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017744s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017744Orig1s026ltr.pdf
12/17/2001 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/17/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
05/25/2001 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/03/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
01/07/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
01/07/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
10/08/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
01/27/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
08/13/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
08/19/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
08/29/1996 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/29/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
08/29/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/29/1992 SUPPL-10 Labeling

Label is not available on this site.
01/29/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
12/03/1991 SUPPL-5 Labeling

Label is not available on this site.
08/19/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
07/20/1988 SUPPL-3 Labeling

Label is not available on this site.
04/21/1982 SUPPL-2 Labeling

Label is not available on this site.
12/28/1981 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/28/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017744s026lbl.pdf
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