Application 021472
- Type
- NDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDOL LIQUID GELS | IBUPROFEN | CAPSULE;ORAL | 200MG | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69810 | SUPPL | 2022-01-05 |
| 69074 | SUPPL | 2021-10-22 |
| 47594 | SUPPL | 2017-03-20 |
| 47574 | SUPPL | 2017-03-17 |
| 5469 | SUPPL | 2010-05-03 |
| 27883 | SUPPL | 2009-04-21 |
| 27882 | SUPPL | 2009-02-23 |
| 5468 | SUPPL | 2006-12-28 |
| 27880 | SUPPL | 2006-03-14 |
| 15547 | SUPPL | 2006-03-14 |
| 27881 | SUPPL | 2006-01-19 |
| 42184 | ORIG | 2004-11-22 |
| 15546 | SUPPL | 2004-02-03 |
| 27879 | SUPPL | 2004-02-02 |
| 27878 | ORIG | 2002-10-18 |