Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020405
Company: CONCORDIA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANOXIN DIGOXIN 0.0625MG TABLET;ORAL Prescription None Yes No
LANOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription AB Yes No
LANOXIN DIGOXIN 0.1875MG TABLET;ORAL Prescription None Yes No
LANOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription AB Yes Yes
LANOXIN DIGOXIN 0.375MG TABLET;ORAL Discontinued None No No
LANOXIN DIGOXIN 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
09/30/1997 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020405_lanoxin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020405s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020405Orig1s013ltr.pdf
09/03/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/28/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020405Orig1s011ltr.pdf
11/22/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/21/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/17/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020405Orig1s007ltr.pdf
11/14/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020405s006ltr.pdf
08/13/2012 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020405Orig1s005ltr.pdf
02/05/2010 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020405s004ltr.pdf
12/07/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/01/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020405s013lbl.pdf
07/28/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf
10/17/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf
08/13/2012 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf
11/14/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf
02/05/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf

LANOXIN

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 077002 HIKMA INTL PHARMS
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 078556 IMPAX LABS
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 040282 MYLAN PHARMS INC
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 076268 STEVENS J
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 076363 SUN PHARM INDS INC
LANOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription Yes AB 020405 CONCORDIA PHARMS INC

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 077002 HIKMA INTL PHARMS
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 078556 IMPAX LABS
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 040282 MYLAN PHARMS INC
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 076268 STEVENS J
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 076363 SUN PHARM INDS INC
LANOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription Yes AB 020405 CONCORDIA PHARMS INC

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