Application 021037
- 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55015 | SUPPL | 2018-07-26 |
| 55014 | SUPPL | 2018-07-26 |
| 54990 | SUPPL | 2018-07-26 |
| 54988 | SUPPL | 2018-07-26 |
| 54987 | SUPPL | 2018-07-26 |
| 53891 | SUPPL | 2018-05-01 |
| 53849 | SUPPL | 2018-04-27 |
| 14222 | SUPPL | 2015-09-21 |
| 26559 | SUPPL | 2015-08-03 |
| 35953 | SUPPL | 2014-06-17 |
| 4127 | SUPPL | 2014-06-12 |
| 14221 | SUPPL | 2013-10-22 |
| 26558 | SUPPL | 2013-10-18 |
| 26557 | SUPPL | 2012-04-02 |
| 35952 | SUPPL | 2012-03-29 |
| 44088 | ORIG | 2011-12-21 |
| 4126 | SUPPL | 2010-12-22 |
| 14220 | SUPPL | 2010-12-20 |
| 14219 | SUPPL | 2010-09-07 |
| 4124 | SUPPL | 2010-08-31 |
| 26556 | SUPPL | 2009-05-29 |
| 35951 | SUPPL | 2009-05-25 |
| 35950 | SUPPL | 2007-09-06 |
| 4125 | SUPPL | 2007-09-06 |
| 26555 | SUPPL | 2006-09-15 |
| 4123 | SUPPL | 2004-09-17 |
| 21365 | ORIG | 2004-06-09 |