Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020405
Company: CONCORDIA
Company: CONCORDIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANOXIN | DIGOXIN | 0.0625MG | TABLET;ORAL | Prescription | AB | Yes | No |
LANOXIN | DIGOXIN | 0.125MG | TABLET;ORAL | Prescription | AB | Yes | No |
LANOXIN | DIGOXIN | 0.1875MG | TABLET;ORAL | Discontinued | 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 |
---|---|---|---|---|---|
04/29/2024 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020405Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020405Orig1s017ltr.pdf | |
02/22/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020405s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020405Orig1s015ltr.pdf | |
08/24/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020405s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020405Orig1s014ltr.pdf | |
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 |
---|---|---|---|---|---|
04/29/2024 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020405Orig1s017lbl.pdf | |
02/22/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020405s015lbl.pdf | |
08/24/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020405s14lbl.pdf | |
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; 0.0625MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIGOXIN | DIGOXIN | 0.0625MG | TABLET;ORAL | Prescription | No | AB | 214982 | AUROBINDO PHARMA LTD |
DIGOXIN | DIGOXIN | 0.0625MG | TABLET;ORAL | Prescription | No | AB | 215307 | NOVITIUM PHARMA |
LANOXIN | DIGOXIN | 0.0625MG | TABLET;ORAL | Prescription | Yes | AB | 020405 | CONCORDIA |
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 | 214982 | AUROBINDO PHARMA LTD |
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 | 215307 | NOVITIUM PHARMA |
DIGOXIN | DIGOXIN | 0.125MG | TABLET;ORAL | Prescription | No | AB | 040282 | RISING |
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 |
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 | 214982 | AUROBINDO PHARMA LTD |
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 | 215307 | NOVITIUM PHARMA |
DIGOXIN | DIGOXIN | 0.25MG | TABLET;ORAL | Prescription | No | AB | 040282 | RISING |
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 |