Application 020883
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARGATROBAN | ARGATROBAN | INJECTABLE;INJECTION | 250MG/2.5ML (100MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0930 | ARGATROBAN | argatroban | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0930 | ARGATROBAN | argatroban | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0930 | ARGATROBAN | argatroban | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0930 | ARGATROBAN | argatroban | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49363 | SUPPL | 2017-08-15 |
| 49290 | SUPPL | 2017-08-09 |
| 35569 | SUPPL | 2016-06-01 |
| 26122 | SUPPL | 2016-05-27 |
| 13666 | SUPPL | 2014-03-11 |
| 3647 | SUPPL | 2014-03-11 |
| 24183 | SUPPL | 2008-07-16 |
| 13665 | SUPPL | 2008-05-19 |
| 26121 | SUPPL | 2008-05-08 |
| 26120 | SUPPL | 2005-09-08 |
| 3646 | SUPPL | 2005-04-12 |
| 3645 | SUPPL | 2003-11-13 |
| 21040 | ORIG | 2002-04-05 |
| 35568 | SUPPL | 2002-04-03 |
| 26119 | SUPPL | 2002-04-03 |
| 13664 | ORIG | 2000-06-30 |
| 3644 | ORIG | 2000-06-30 |
| 53180 | ORIG | 1900-01-01 |
| 53179 | ORIG | 1900-01-01 |