Application 019596
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAGNEVIST | GADOPENTETATE DIMEGLUMINE | INJECTABLE;INJECTION | 469.01MG/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-147 | Gadopentetate dimeglumine | Gadopentetate dimeglumine | Alvogen, Inc | NDA AUTHORIZED GENERIC | Current |
| 50419-188 | Magnevist | Gadopentetate dimeglumine | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-188 | Magnevist | Gadopentetate dimeglumine | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-188 | Magnevist | Gadopentetate dimeglumine | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-188 | Magnevist | Gadopentetate dimeglumine | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55030 | SUPPL | 2018-07-27 |
| 55013 | SUPPL | 2018-07-26 |
| 55012 | SUPPL | 2018-07-26 |
| 54986 | SUPPL | 2018-07-26 |
| 54985 | SUPPL | 2018-07-26 |
| 53890 | SUPPL | 2018-06-20 |
| 53851 | SUPPL | 2018-04-27 |
| 47811 | SUPPL | 2017-03-31 |
| 1412 | SUPPL | 2014-06-12 |
| 11556 | SUPPL | 2013-10-22 |
| 1411 | SUPPL | 2013-10-18 |
| 1410 | SUPPL | 2012-04-02 |
| 33811 | SUPPL | 2012-03-29 |
| 40938 | SUPPL | 2011-02-04 |
| 20265 | SUPPL | 2011-02-04 |
| 1409 | SUPPL | 2010-12-22 |
| 11555 | SUPPL | 2010-12-20 |
| 33809 | SUPPL | 2010-09-07 |
| 17476 | SUPPL | 2010-08-31 |
| 17477 | SUPPL | 2009-05-29 |
| 11554 | SUPPL | 2009-05-25 |
| 33810 | SUPPL | 2007-09-06 |
| 1408 | SUPPL | 2007-09-06 |
| 1407 | SUPPL | 2006-09-15 |
| 44035 | ORIG | 2006-06-09 |
| 11553 | SUPPL | 2005-01-26 |
| 1406 | SUPPL | 2005-01-26 |