Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076268
Company: STEVENS J
Company: STEVENS J
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 |
---|---|---|---|---|---|---|---|
07/26/2002 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76268_Digoxin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076268_digoxin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/19/2007 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf |
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 |