Application 006188
- Type
- NDA
- Sponsor
- DAVA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPYLTHIOURACIL | PROPYLTHIOURACIL | TABLET;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67253-651 | Propylthiouracil | Propylthiouracil | Par Pharmaceutical | NDA | Current |
| 67253-651 | Propylthiouracil | Propylthiouracil | Par Pharmaceutical, Inc. | NDA | Current |
| 68084-964 | Propylthiouracil | Propylthiouracil | American Health Packaging | NDA | Current |
| 68084-964 | Propylthiouracil | Propylthiouracil | American Health Packaging | NDA | Current |
| 68084-964 | Propylthiouracil | Propylthiouracil | American Health Packaging | NDA | Current |
| 68084-964 | Propylthiouracil | Propylthiouracil | American Health Packaging | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55534 | SUPPL | 2018-09-20 |
| 55533 | SUPPL | 2018-09-20 |
| 32942 | SUPPL | 2016-03-08 |
| 79 | SUPPL | 2016-01-20 |
| 10686 | SUPPL | 2015-02-12 |
| 78 | SUPPL | 2015-02-12 |
| 77 | SUPPL | 2011-07-29 |
| 29 | SUPPL | 2011-07-29 |
| 32941 | SUPPL | 2011-07-28 |
| 10685 | SUPPL | 2011-07-28 |
| 76 | SUPPL | 2010-04-05 |
| 23087 | SUPPL | 2010-04-04 |
| 10684 | SUPPL | 2010-04-04 |
| 32940 | SUPPL | 2008-11-28 |
| 10683 | SUPPL | 2008-11-28 |