Application 021648
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIGOXIN | DIGOXIN | ELIXIR;ORAL | 0.05MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0057 | Digoxin | Digoxin | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 17856-0057 | Digoxin | Digoxin | Atlantic Biologicals Corps | NDA | Current |
| 68094-751 | Digoxin | Digoxin | Precision Dose, Inc. | NDA | Current |
| 68094-752 | Digoxin | Digoxin | Precision Dose Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81998 | SUPPL | 2025-04-25 |
| 81947 | SUPPL | 2025-04-21 |
| 78295 | SUPPL | 2024-04-29 |
| 78272 | SUPPL | 2024-04-26 |
| 55334 | SUPPL | 2018-08-28 |
| 55300 | SUPPL | 2018-08-24 |
| 46047 | SUPPL | 2016-12-15 |
| 46018 | SUPPL | 2016-12-05 |
| 15920 | SUPPL | 2015-07-30 |
| 28311 | SUPPL | 2015-07-29 |
| 5909 | SUPPL | 2012-10-02 |
| 37396 | SUPPL | 2012-09-28 |
| 37395 | SUPPL | 2011-12-02 |
| 28310 | SUPPL | 2011-11-22 |
| 42251 | SUPPL | 2011-11-02 |
| 5908 | SUPPL | 2011-10-03 |
| 37394 | SUPPL | 2011-09-27 |
| 21767 | ORIG | 2007-06-04 |
| 37393 | ORIG | 2004-08-31 |
| 28309 | ORIG | 2004-08-31 |