Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215307
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
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 |
DIGOXIN | DIGOXIN | 0.0625MG | 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 |
---|---|---|---|---|---|---|---|
11/22/2021 | ORIG-1 | Approval | STANDARD |
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 |
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 |