Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083391
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIGOXIN | DIGOXIN | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 10/24/1975 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/10/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/25/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/13/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/23/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/29/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/23/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
DIGOXIN
INJECTABLE;INJECTION; 0.25MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIGOXIN | DIGOXIN | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040481 | SANDOZ |
| DIGOXIN | DIGOXIN | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 083391 | WEST-WARD PHARMS INT |
| LANOXIN | DIGOXIN | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 009330 | COVIS |