Drugs@FDA: FDA-Approved Drugs
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIGOXIN | DIGOXIN | 0.125MG | TABLET;ORAL | Prescription | AB | No | No |
DIGOXIN | DIGOXIN | 0.25MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/23/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40282ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40282_Digoxin.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/10/2020 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
01/28/2019 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
09/03/2014 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040282Orig1s013ltr.pdf |
06/12/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/18/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/18/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
02/07/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
10/31/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
02/07/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
DIGOXIN
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 |