Application 207027
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMACTA KIT | ELTROMBOPAG OLAMINE | FOR SUSPENSION;ORAL | EQ 25MG ACID/PACKET | Yes | Yes |
| 002 | PROMACTA KIT | ELTROMBOPAG OLAMINE | FOR SUSPENSION;ORAL | EQ 12.5MG ACID/PACKET | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0697 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0972 | PROMACTA | eltrombopag olamine | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82506 | SUPPL | 2025-06-09 |
| 82496 | SUPPL | 2025-06-09 |
| 82495 | SUPPL | 2025-06-09 |
| 73733 | SUPPL | 2023-03-10 |
| 73721 | SUPPL | 2023-03-10 |
| 70693 | SUPPL | 2022-04-05 |
| 70692 | SUPPL | 2022-04-05 |
| 70683 | SUPPL | 2022-04-04 |
| 66093 | SUPPL | 2021-02-04 |
| 66090 | SUPPL | 2021-02-04 |
| 66089 | SUPPL | 2021-02-04 |
| 66087 | SUPPL | 2021-02-04 |
| 66073 | SUPPL | 2021-02-03 |
| 62798 | SUPPL | 2020-05-01 |
| 62797 | SUPPL | 2020-05-01 |
| 62768 | SUPPL | 2020-04-30 |
| 58422 | SUPPL | 2019-04-25 |
| 58421 | SUPPL | 2019-04-25 |
| 55814 | SUPPL | 2018-10-04 |
| 55752 | SUPPL | 2018-10-01 |
| 55000 | SUPPL | 2018-07-26 |
| 54969 | SUPPL | 2018-07-25 |
| 54388 | SUPPL | 2018-05-31 |
| 54372 | SUPPL | 2018-05-30 |
| 48931 | SUPPL | 2017-07-10 |
| 47549 | SUPPL | 2017-03-14 |
| 47522 | SUPPL | 2017-03-10 |
| 45616 | SUPPL | 2016-10-17 |
| 45555 | SUPPL | 2016-10-14 |
| 43531 | ORIG | 2016-06-03 |
| 24523 | ORIG | 2016-06-03 |
| 40578 | ORIG | 2015-08-25 |
| 32840 | ORIG | 2015-08-25 |
| 51702 | ORIG | 2011-11-23 |
| 51700 | ORIG | 2010-01-25 |
| 68839 | ORIG | 1900-01-01 |
| 67193 | SUPPL | 1900-01-01 |
| 62979 | SUPPL | 1900-01-01 |